Protocol Fast Facts

[ Alliance, CTSU, NRG & SWOG ]

Brain Protocols: Glioblastoma or Gliosarcoma

1. Alliance A071102 / NCT02152982 
(Temporarily closed to accrual effective 10/21/2016)
Newly Diagnosed Glioblastoma or Gliosarcoma with MGMT Promoter Hypermethylation

Eligibility: (Pre-reg) - Newly diagnosed Grade IV intercranial glioblastoma or gliosarcoma with tissue available for central pathology review and MGMT methylation status evaluation.
(Registration) – Tumor MGMT promoter hypermethylation and pathology review confirmed by central path review; Measureable or specific non-measureable disease; Must have completed RT and concomitant TMZ therapy; No uncontrolled seizure disorder; No major surgery within last 14 days prior registration; PS 0-2.
RX: Temozolomide + Veliparib versus Temozolomide + Placebo
(VELAPARIB/PLACEBO SUPPLIED)

Breast Protocols: Neoadjuvant

1. Alliance A011106 / NCT01953588
(ALTERNATE trial) ER+ Breast Cancer Neoadjuvant Treatment for Postmenopausal Women

Eligibility: Female; age > 18; PS 0-2; Postmenopausal; Clinical T2-T4c, any N, M0 invasive breast cancer diagnosed by needle biopsy; Goal of surgery: complete exicision of tumor in breast and lymph node; Palpable, solitary, bidimensional measured lesion of at least 2.0 cm; multi-focal and multi-lesional breast cancer are not eligible; ER+ with Allred score 6, 7, or 8; HER2 negative; Mammogram and ultrasound done w/in 42 days prior to registration; Research biopsies required at baseline/week 4/surgery.
RX: (neoadjuvant): Arm I - anastrozole daily x 6 cycles vs. Arm II - fulvestrant x 6 cycles vs. Arm III - anastrozole + fulvestrant x 6 cycles; Interim Biopsy at wk 4: (If Ki67 > 10% - change tx to neoadj chemo (wkly Taxol preferred) → Surgery → Adjuvant therapy of MD choice. If Ki67 < 10% - continue current assigned neoadj treatment → Surgery and PEPI score determined: (If PEPI 0 - adjuv chemo NOT recommended, then adjuvant endocrine tx based on initial randomized assignment: Arm I - anastrozole x 4.5 yrs vs. Arm II - fulvestrant x 1.5 yrs → anastrozole x 3 yrs vs. Arm III - fulvestrant + anastrozole x 1.5 yrs → anastrozole x 3 yrs). (If PEPI > 0 - Adjuvant Chemo and endocrine therapy of MD choice). (FULVESTRANT SUPPLIED)

2. Alliance A011202 / NCT01901094
Positive Axillary Nodes after Neoadjuvant Chemo

Eligibility: Clinical T1-T3 N1 M0 breast cancer before neoadjuvant chemo; No inflammatory br ca; Pathologic positive FNA or core bx of axillary nodal involvement before or w/in 14 days after start neoadjuvant chemo; Completed at least 4 cycles of neoadjuvant chemo ; no chemo planned after surgery; HER2 pos tumor must rec neoadj anti-HER2 tx; After neoadj chemo, must have clinically negative axilla; NO neoadj endocrine tx and NO neoadj RT; No sentinel LN prior or during neoadj chemo; PS 0-1; Breast surgery must be completed within 56 days of completing neoadj chemo.
RX: (Intra-operative Reg): If Negative LNs: No study randomization. Offer NSABP B-51 trial. If Positive LNs: Randomize: ALND + Nodal RT versus Axillary and Nodal RT (NO DRUGS SUPPLIED)

3. NRG-BR005 / NCT03188393
Accuracy of Breast Tumor Biopsies with Complete Response After NeoAdjuvant Chemo to Explore Feasibility of Breast Conserving Treatment Without Surgery

Eligibility: Female/Male; age > 18; ER/and PR and HER2 analysis; Biopsy marker placed in tumor bed prior neoadjuvant chemo; Must undergo tri-modality imaging after neoadjuvant chemo (breast ultrasound, MRI and mammography); Completion of neoadjuvant chemo with a clinical complete response (by clinical examination) and complete or near complete response (on breast imaging); Must be undergoing breast conserving therapy with stereotactic-vacuum-assisted breast biopsy w/clip placement after neoadjuvant chemo; No hx of prior radiation therapy in the affected breast; Lobular carcinoma are not eligible; PS 0-1.
Assessment: Image Guided, Stereotactic Core Biopsy post neoadjuvant chemo followed by Breast Conserving Surgery. (NO DRUGS SUPPLIED)

4. NSABP B-51 (RTOG 1304) / NCT01872975
RT for Converted Negative Axillary Nodes after Neoadjuvant Chemo

Eligibility: Female; PS 0-1; Clinically T1-T3 N1 before neoadj chemo; Pathologic positive FNA or core bx of axillary nodal involvement before neoadj chemo; NO sentinel lymph node bx before neoadj chemo; ER and/or Pgr & HER2 analysis of primary breast before neoadj chemo; completed 12 wks of standard neoadjuvant chemo; if adjuvant chemo after surgery, max of 12 wks chemo before randomization; HER2 pos tumor must rec neoadj anti-HER2 tx; all removed axillary nodes must be histologically free from cancer at surgery; clear margins; max interval between last surgery/or last adj chemo to randomization is 56 days; no mets; no T4 or inflammatory br CA; no RT prior to randomization. ** (If positive LN post neoadj chemo, offer Alliance A011202 trial)
RX: Standard RT + No Regional Nodal RT versus Standard RT + Regional Nodal RT. (NO DRUGS SUPPLIED)

Breast Protocols: Stages I-III

1. Alliance A011502 / NCT02927249
The ABC Trial for Node Positive, HER2 Negative Breast Cancer

Eligibility: Men or women eligible; Age > 18 and <70; Must enroll within 1 year after diagnosis; Node positive, HER2 negative breast cancer; Stage II or III and free of recurrence; Last dose of chemo or RT must be at least 60 days prior reg; Concurrent hormonal therapy is allowed; Regular NSAID/aspirin (> 5 days/wk) use must be stopped for one year prior study entry and throughout study period; PS 0-2.
RX: Aspirin 300 mg daily x 5 years versus Placebo daily x 5 years.

2. ECOG-ACRIN EA1131 / NCT02445391
Residual Triple Negative Breast Cancer with PAM50 Analysis Following Neoadjuvant Chemo

Eligibility: Female or Male; Age > 18; Confirmed triple negative (ER/PgR/HER2 negative) invasive breast cancer; Clinical stage II-III (no stage IV); Completed neoadjuvant taxane +/- anthracycline (must NOT have received Cisplatin or Carboplatin or Capecitabine with neoadjuvant chemo); Residual invasive cancer defined as > 1 cm contiguous focus in breast at the time of definitive surgery; Residual disease tissue available for central lab PAM50 analysis to determine “basal-like” expression within 21 weeks post surgery; PS 0-1.
RX: Cisplatin or Carboplatin x 4 cycles versus Capecitabine x 6 cycles. (NO DRUGS SUPPLIED)

3. NRG-BR003 / NCT02488967
Triple-Negative Breast Cancer (Node Positive or High-Risk Node Negative)

Eligibility: Female or Male; PS 0-1; Histologic unilateral invasive breast adenocarcinoma; pT1-3, pN0-3; If pN0, tumor must be > 3.0 cm; ER/PgR/HER2 negative; clear margins; Must be randomized w/in 60 days of last breast cancer surgery; No inflammatory breast ca; No synchronous or previous contralateral invasive br ca.
RX:AC (Doxorubicin + Cyclophosphamide) → WP (weekly Paclitaxel) versus AC → WP + Carboplatin (NO DRUGS SUPPLIED)

4. NSABP B-55 / BIG 6-13 / NCT02032823
BRCA 1 or BRCA 2 Mutation, HER2 Negative, High Risk Breast Cancer Adjuvant Treatment
Eligibility: Female or Male; Must be > 18 y/o; Histologic, non-metastatic primary invasive adenocarcinoma of the breast; Documented BRCA 1 or BRCA 2 deleterious or suspected deleterious mutation; HER2 negative; Must be High Risk defined as either: 1.) For those after initial surgery and adjuvant chemo: TNBC w/axillary node positive (any tumor size) OR axillary node negative (with primary pathological tumor size > 2 cm OR ER/PgR positive with > 4 positive lymph nodes; 2.) For those underwent neoadjuvant chemo followed by surgery: TNBC w/residual breast cancer in breast and/or resected lymph nodes (non-pCR) OR ER/PgR positive w/residual breast cancer in breast and/or resected lymph nodes (non-pCR) AND a CPS& EG score >3; Breast conservation patients must have adjuvant RT; Completed at least 6 cycles of neoadjuvant or adjuvant chemo containing anthracyclines, taxanes or combo of both; PS 0-1.
RX:Olaparib 300 mg orally twice daily x 12 months versus Placebo orally twice daily x 12 months
(OLAPARIB/PLACEBO SUPPLIED)

5. SWOG S1207 / NCT01674140
High Risk, HER2 Neg Breast Cancer w/planned Hormonal Therapy (BAHO blood submission suspended eff: 12/1/16)

Eligibility:  Invasive breast carcinoma; ER positive and/or PgR positive status and HER2 negative; Planned standard adjuvant endocrine therapy; Must meet one of these High Risk groups: complete adj chemo, lymph node negative, tumor > 2 cm and RS score >25 OR complete adj chemo, 1-3 positive lymph nodes, and either RS >25 or tumor histological grade III OR complete adj chemo, 4 or more positive lymph nodes OR complete neoadjuvant chemo, 1 or more positive lymph nodes prior or after neoadj chemo.; no stage IV; no inflammatory br ca; multifocal, multicentric and synchronous bilateral ok; must register w/in 21 wks after last chemo; PS 0-2.
RX: Everolimus 10 mg versus Placebo x 1 year + appropriate endocrine therapy x 5 years. (EVEROLIMUS SUPPLIED)

6. SWOG S1418/BR006 / NCT02954874
Residual TNBC or Positive Lymph Nodes After Neoadjuvant Chemo

Eligibility: Age > 18; Histologically confirmed ER neg, PR neg and HER2 neg (triple negative, TNBC) with residual invasive br ca (> 1 cm and/or have positive lymph nodes (ypN+) on surgical pathology) after completion of 16-24 wks of neoadjuvant chemo; No metastatic disease; Must have adequate tumor tissue from residual disease for PD-L1 testing; Ok to also receive post-op (adjuvant) chemo up to 24 wks after completion of surgery at physician discretion; Final breast surgery must be w/in 90 days prior to screening registration (if no post-op adjuvant chemo), or w/in 210 days prior to screening registration (if completed post op adjuvant chemo); If xRT indicated, it should be received after randomization when possible (xRT concomitant with MK-3475 is ok if randomized to this arm); No prior anti-PD-L1, anti PD-1, anti-CTLA4 or similar drugs; PS < 2.
RX: Observation versus MK-3475 (pembrolizumab) q 3 wks x 52 wks.
(MK-3475 (pembrolizumab) SUPPLIED)

Breast Protocols: Locally Advanced/Recurrent/Metastatic

1. ECOG-ACRIN E2112 / NCT02115282
Hormone Receptor Positive Advanced Breast Cancer

Eligibility: Men and women eligible; Age > 18 y/o; ER/PR positive breast adenocarcinoma; HER2 negative; Must have measurable or non-measurable Stage III/locally advanced or metastatic carcinoma of the breast; Any menopausal status; No CNS mets; May have received only one prior chemo for metastatic disease.
RX: Exemestane + Entinostat versus Exemestane + Placebo
(ENTINOSTAT/PLACEBO SUPPLIED)

2. SWOG S1416 / NCT02595905
Stage IV, Triple Negative and/or BRCA Mutation-Associated Breast Cancer

Eligibility: Women or Men; Age > 18 y/o; Metastatic breast cancer; HER2 negative; Triple Negative (ER and PR < 1%) and/or BRCA mutation; Bio-specimen available for submission; < 1 prior cytotoxic regimen for metastatic disease; No prior Cisplatin or PARP inhibitors; If brain mets, must meet additional criteria.
RX: Cisplatin + ABT-888 versus Cisplatin + Placebo
(ABT-888/Placebo SUPPLIED)

Breast Protocols: Miscellaneous

1. Alliance A011104 / NCT01805076 (selected MRI imaging sites only)
Preoperative Breast MRI on Outcomes, Costs and Quality of Life

Eligibility: Female; Pathological diagnosis of breast cancer with clinical stage I-II; Must have either ER/PR negative and HER2 negative OR ER/PR negative and HER2 positive tumors; no bilateral br ca; no known deleterious mutations in BRCA genes; no hx of hormonal tx; no hx of chemo within last 6 mos; no planned neoadjuv chemo or partial breast irradiation after surgery; eligible for breast conserving therapy; no multi-centric/focal disease requiring multiple lumpectomies; suitable for MRI; no prior breast MRI w/in prior 12 mos.
RX: No MRI + BCT versus MRI + BCT or Mastectomy (NO DRUGS SUPPLIED)

2. Alliance A221102 / NCT01573442     
Arthralgias Caused by Aromatase Inhibitors in Postmenopausal Breast Cancer Women

Eligibility: Woman; Age > 18 y/o that is postmenopausal by surgery, radiotherapy or natural amenorrhea > 12 months; Receiving daily anastrozole (1 mg ) or letrozole (2.5 mg) orally, for > 21 days prior to registration and plans to continue throughout the study (exemestane not eligible); BMI between 18 and 35 kg/m2; Pain > 5 of 10 arthralgia (in hands, wrist, knees or hips) felt to be attributed to AI; PS 0-2; Willing to provide blood samples for research purposes; No recurrent or metastatic disease; No hormone replacement therapy (HRT); No concurrent RT or chemo.
RX: Topical Testosterone Gel x 6 months versus Topical Placebo Gel x 6 months
(TOPICAL TESTOSTERONE/PLACEBO GEL SUPPLIED)

3. Alliance A221405 / NCT02308085
(POSITIVE trial) Pregnancy Outcome and Safety of Interrupting Endocrine Responsive Breast Cancer

Eligibility: Female; Patient wishes to become pregnant; Premenopausal at breast cancer diagnosis; Age > 18 and < 42 at enrollment; Received adjuvant endocrine therapy for > 18 months but < 30 months for early breast cancer (stage I-III, M0, ER and/or PgR positive); Endocrine therapy must have stopped w/in 1 months prior to enrollment.

Plan and Assessments: Temporarily stop endocrine therapy; Must wait 3-5 months after stopping endocrine therapy before attempting pregnancy; Disease assessments, blood samples & pregnancy status performed at months: 3, 6, 12, 18 and 24; If pregnancy successful: pregnancy and birth outcome information collected and endocrine therapy resumed within 2 years of interruption; If pregnancy unsuccessful, will resume endocrine therapy within 2 years of interruption; Follow up will continue for up to 10 years.

1. ECOG-ACRIN E1Z11 / NCT01824836  
(Limited accrual only to Asians and Native Hawaiian/Pacific Islanders)
Genetic Predictors of AI (anastrozole) Musculoskeletal Symptoms (AIMSS)

Eligibility: Female > 18 y/o; Postmenopausal; ER/PgR positive Stage I-III adenocarcinoma of the breast and completed planned local therapy (ie. surgery, adj chemo, RT); not received any PRIOR AI; prior Tamoxifen allowed; Plans to treat with anastrozole (arimidex) for at least 12 mos; PS 0-2; not currently taking medications for active, chronic conditions for treating pain or have an effect on pain; patients with no worse pain than 3 out of 10 scale.
Assessments: Physical Exams (assess for AIMSS), Questionnaires every 3 months and blood collections up to 12 months.  
RX: Anastrozole, 1 mg daily (NO DRUG SUPPLIED)

Cancer Care Delivery Research (CCDR)

1. S1417CD / NCT02728804
Metastatic Colorectal Cancer Financial Impact Assessment Tool

Eligibility:  Age > 18 y/o; Newly dx metastatic colon or rectal cancer or metastatic recurrence after prior treatment for Stage I-III disease; Must be < 120 days after metastatic diagnosis at the time of registration; Systemic chemo and/or biology therapy must be planned to be administered w/in 30 days after registration OR must have been initiated < 60 days prior registration; Willing to provide personal information to provide “soft pull” access to credit report data; Able to complete questionnaires in English; Caregiver consent participation (optional). Assessments: Patient (and optional Caregiver) Questionnaires at timepoints: Baseline, month 3, month 6, month 9, month 12. Access to credit report data at timepoints: Baseline, 12 months or off protocol.
(NO DRUGS SUPPLIED)

2. SWOG S1415CD / NCT02728596 (CCRMC site only)
Trial Assessing Colony Stimulating Factor Prescribing Effectiveness and Risk (TrACER)

  • CCRMC site Randomized to Intervention Arm 3 (Clinic Group #3) -  which includes implemented standing Primary Prophylactic Colony Stimulating Factor (PP-CSF) orders for high and intermediate febrile neutropenia risk regimens, and excludes PP-CSF orders for low febrile neutropenia risk regimens).

Eligibility: Age > 18 y/o; Patients with current diagnosis of breast cancer, NSCLC, or colorectal cancer; Metastatic or non-metastatic; Plan to receive one of the study-allowed regimens listed as initial treatment (1st cycle) for current diagnosis; Registered prior to 1st cycle of systemic therapy; No known contraindications to CSF; Must be able to complete patient study forms in English or Spanish.
Assessments: Data collection and patient questionnaires - After 1st cycle or therapy, Month 1, Month 6 and Month 12. (NO DRUGS SUPPLIED)

Cancer Control/Symptom Management

1. Alliance A011104 / NCT01805076
(selected MRI imaging sites only)
Preoperative Breast MRI on Outcomes, Costs and Quality of Life

Eligibility: Female; Pathological diagnosis of breast cancer with clinical stage I-II; Must have either ER/PR negative and HER2 negative OR ER/PR negative and HER2 positive tumors; no bilateral br ca; no known deleleterious mutations in BRCA genes; no hx of hormonal tx; no hx of chemo within last 6 mos; no planned neoadjuv chemo or partial breast irradiation after surgery; eligible for breast conserving therapy; no multi-centric/focal disease requiring multiple lumpectomies; suitable for MRI; no prior breast MRI w/in prior 12 mos.
RX: No MRI + BCT versus MRI + BCT or Mastectomy (NO DRUG SUPPLIED)

2. Alliance A011401 / NCT02750826 (HO1 sub-study closed eff: 7/6/17)
Breast Cancer Weight Loss Study

Eligibility: Female; Age > 18 y/o; Histologic diagnosis of invasive breast cancer w/in last 12 months; HER-2 negative; Eligible stages include: ER and PR negative with T2-T3N0 or T0-3N1-3; If ER and/or PR positive with T0-3N1-3 or T3N0; All neo-/adj- chemo and surgery completed at least 21 days prior to registration; PS 0-1; BMI > 27 kg/m2; No diabetes mellitus being tx with insulin or sulfonylurea drugs; Ability to walk at least 2 blocks (any pace); Read and comprehend English.
RX: 2 Year Health Education Intervention versus 2 Year Health Education Intervention + Supervised Weight Loss Intervention (WEIGHT LOSS and HEALTH EDUCATION PROGRAMS SUPPLIED. NO DRUGS SUPPLIED)

3. Alliance A221102 / NCT01573442
Arthralgias Caused by Aromatase Inhibitors in Postmenopausal Breast Cancer Women

Eligibility: Woman; Age > 18 y/o that is postmenopausal by surgery, radiotherapy or natural amenorrhea > 12 months; Receiving daily anastrozole (1 mg ) or letrozole (2.5 mg) orally, for > 21 days prior to registration and plans to continue throughout the study (exemestane not eligible); BMI between 18 and 35 kg/m2; Pain > 5 of 10 arthralgia (in hands, wrist, knees or hips) felt to be attributed to AI; PS 0-2; Willing to provide blood samples for research purposes; No recurrent or metastatic disease; No hormone replacement therapy (HRT); No concurrent RT or chemo.
RX: Topical Testosterone Gel x 6 months versus Topical Placebo Gel x 6 months
(TOPICAL TESTOSTERONE/PLACEBO GEL SUPPLIED)

4. ECOG-ACRIN E1Z11 / NCT01824836
(Limited accrual only to Asians and Native Hawaiian/Pacific Islanders)
Genetic Predictors of AI (anastrozole) Musculoskeletal Symptoms (AIMSS)

Eligibility: Female > 18 y/o; Postmenopausal; ER/PgR positive Stage I-III adenocarcinoma of the breast and completed planned local therapy (ie. surgery, adj chemo, RT); not received any PRIOR AI; prior Tamoxifen allowed; Plans to treat with anastrozole (arimidex) for at least 12 mos; PS 0-2; not currently taking medications for active, chronic conditions for treating pain or have an effect on pain; patients with no worse pain than 3 out of 10 scale.
Assessments: Physical Exams (assess for AIMSS), Questionnaires every 3 months and blood collections up to 12 months.  
RX: Anastrozole, 1 mg daily (NO DRUG SUPPLIED)

5. SWOG S0820 / NCT01349881
Prevent Recurrence of High Risk Adenomas and Second Primary Colon or Rectal Cancers

Eligibility: Age > 18 y/o; Hx Stage 0, I, II, III colon or rectal cancer treated per standard of care (resection or with adj chemo); Registered between 180 days and 456 days (inclusive) of primary resection; No cardiovascular risk factors; Total proctocolectomy is ineligible; No known allergic-type reactions with aspirin or NSAIDs; No hx of gastric/duodenal ulcer w/in last 12 months; PS 0-1; No plan for additional RT or chemo; No concomitant corticosteroids, NSAIDs, anticoagulants.
RX: Eflornithine placebo + Sulindac x 36 months versus Eflornithine + Sulindac x 36 months. (Arms: Eflornithine + Sulindac placebo and Eflornithine placebo + Sulindac closed to accrual)
(STUDY DRUGS SUPPLIED)

GI Protocols: Colo-Rectal

1. CTSU N1048 / NCT01515787
Combined Modality for Locally Advanced Rectal Cancer Undergoing Surgery

Eligibility: Diagnosis of rectal adenocarcinoma; measurable disease clinically or by imaging (clinical stage: T2N1, T3N0, T3N1); PS 0-2; candidate for sphincter-sparing surgical resection prior to neoadj tx; preoperative proctoscopy w/distal end of tumor tissue btw 5 and 12 cm from anal verge, inclusive; no prior pelvic radiation; primary surgeon must be study credentialed in Total Mesorectal Excision (TME); Planned standard treatment of combined modality neoadjuvant chemoradiation followed by curative intent surgical resection.
RX: neoadjuv (5FU or capecitabine) + RT →TME surgery → FOLFOX versus
neoadjuv FOLFOX → (restaging):
    If Progression or regression < 20%: (5FU or capecitabine) + RT → TME surgery →
    (If R0), then FOLFOX x 6 OR (If R1 and R2), then (5FU or capecitabine) + RT AND FOLFOX x 4.
    If regression > 20%: TME surgery → (If R0), then FOLFOX x 6 OR (If R1 and R2), then (5FU or capecitabine) + RT AND FOLFOX x 4.
(NO DRUG SUPPLIED)

2. SWOG S0820 / NCT01349881
Prevent Recurrence of High Risk Adenomas and Second Primary Colon or Rectal Cancers

Eligibility: Age > 18 y/o; Hx Stage 0, I, II, III colon or rectal cancer treated per standard of care (resection or with adj chemo); Registered between 180 days and 456 days (inclusive) of primary resection; No cardiovascular risk factors; Total proctocolectomy is ineligible; No known allergic-type reactions with aspirin or NSAIDs; No hx of gastric/duodenal ulcer w/in last 12 months; PS 0-1; No plan for additional RT or chemo; No concomitant corticosteroids, NSAIDs, anticoagulants.
RX: Eflornithine placebo + Sulindac x 36 months versus Eflornithine + Sulindac x 36 months. (Arms: Eflornithine + Sulindac placebo and Eflornithine placebo + Sulindac closed to accrual)
(STUDY DRUGS SUPPLIED)

3. S1417CD / NCT02728804
Metastatic Colorectal Cancer Financial Impact Assessment Tool

Eligibility: Age > 18 y/o; Newly dx metastatic colon or rectal cancer or metastatic recurrence after prior treatment for Stage I-III disease; Must be < 120 days after metastatic diagnosis at the time of registration; Systemic chemo and/or biology therapy must be planned to be administered w/in 30 days after registration OR must have been initiated < 60 days prior registration; Willing to provide personal information to provide “soft pull” access to credit report data; Able to complete questionnaires in English; Caregiver consent participation (optional).
Assessments: Patient (and optional Caregiver) Questionnaires at timepoints: Baseline, month 3, month 6, month 9, month 12. Access to credit report data at timepoints: Baseline, 12 months or off protocol.
(NO DRUGS SUPPLIED)

GI Protocols: Pancreatic

1. SWOG S1505 / NCT02562716
Perioperative Therapy for Resectable Pancreatic Cancer

Eligibility:  Age > 18 and < 75; Histological pancreatic adenocarcinoma; Must have measurable disease with CT or MRI and primary tumor considered surgically resectable; No prior surgery or therapy for pancreatic cancer; PS 0-1; No metastatic disease.
RX: Arm 1: mFOLFIRINOX x 3 cycles, then restaging, (if progression, off treatment) if no progression: SURGERY then mFOLFIRINOX x 3 cycles versus Arm 2: Gemcitabine/nab-Paclitaxel x 3 cycles, then restaging, (if progression, off treatment) if no progression: SURGERY then Gemcitabine/nab-Paclitaxel x 2 cycles. (NO DRUGS SUPPLIED)

2. SWOG S1513 / NCT02890355
Metastatic Pancreatic Cancer

Eligibility: Age > 18; Histologic or cytologically documented pancreatic adenocarcinoma; Must have metastatic, measurable disease; No brain mets; Only one prior regimen of systemic therapy for metastatic disease; Must not have received any prior irinotecan-based chemo and no prior PARP inhibitor therapy; PS 0-1; Must be willing and able to undergo pre-tx biopsy, submit tumor and blood samples.
RX: ABT-888 + modified FOLFIRI versus FOLFIRI (ABT-888 SUPPLIED)

GU Protocols: Renal

1.  ECOG-ACRIN EA8143 / NCT03055013
Peri-operative Treatment vs. Observation in Localized Renal Cell Carcinoma (PROSPER RCC)

Eligibility: Age > 18 y/o; Pre-operative biopsy confirmation of renal cell carcinoma (RCC) within 4 months of randomization; Clinical stage > T2NxM0 disease or T(any)N+ disease for which radical or partial nephrectomy is planned; No clinical or radiological evidence of distant mets (M0); No concurrent or prior systemic or local anti-cancer therapy for RCC; PS 0-1.
RX: neoadjuvant Nivolumab x 2 doses » Nephrectomy » Nivolumab versus Partial or Radical Nephrectomy » Observation.
(NIVOLUMAB SUPPLIED)

GYN Protocols: Ovary

1. GOG 0241 / NCT01081262 (Accrual suspended: 10/28/13)
Stage II-IV or Recurrent stage I, Mucinous Ovarian or Fallopian Tube CA

Eligibility: histological mucinous adenocarcinoma; optimal or suboptimal; no CNS mets; PS 0-2; no primary peritoneal CA; no prior chemo or RT; Negative colonoscopy w/in 1 year; no anticipated surgical procedures during the study.
RX: Paclitaxel+Carboplatin x 6 cycles VS. Oxaliplatin + Capecitabine x 6 cycles VS.  Paclitaxel + Carboplatin + Bevacizumab x 6 cycles followed by Bevacizumab x 12 cycles vs. Oxaliplatin + Capecitabine + Bevacizumab x 6 cycles followed by Bevacizumab x 12 cycles. (BEVACIZUMAB SUPPLIED)

1.  NRG GY-004 / NCT02446600
Recurrent Platinium-Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Eligibility: Platinum-sensitive recurrent (no disease recurrence for > 6 mos after last platinum-based tx) high-grade serious or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; Must have evaluable disease; No prior PARP inhibitor; PS 0-2.
RX: Oliparib versus Oliparib + Cediranib versus Platinum-based chemotherapy (MD discretion) (OLIPARIB AND CEDIRANIB SUPPIED)

Lung Protocols: Non-small Cell

1. Alliance A151216 (ALCHEMIST) / NCT02194838
Screening EGFR, ALK and PD-L1 Genotype Testing in Non-Squamous and Squamous NSCLC

Eligibility: Age > 18 y/o; Clinical stage IB (> 4 cm), II or IIIA NSCLC, completed resected; PS 0-1; No prior neoadjuvant RT or chemo; No interstitial fibrosis or lung disease; No prior treatments with agents targeting EGFR, ALK or PD-1/PD-L1/CTLA-4; Must have adequate formalin fixed paraffin embedded tissue specimen for central genetic testing and research genomics.
Assessments: Tissue specimen submitted for central EGFR and ALK genotyping for non-squamous and PD-L1 genotyping for squamous:

Cohort A
Genetic changes in:
- EGFR+ can enroll to A081105 study
- ALK+ can enroll to E4512 study
- PD-L1+/- (or EGFR/ALK neg) can enroll to EA5142 study
Study follow up to these respective enrolled trials.

Cohort B
Genetic changes in EGFR or ALK or PD-L1 identified but NOT enrolled to specified adjuvant trials. Follow up every 6 months x 5 years.

Cohort C
No genetic changes identified in EGFR or ALK or PD-L1 and not enrolled to specified adjuvant trials. Follow up every 6 months x 5 years.

(NO DRUG SUPPLIED)

2. Alliance A081105 / NCT02193282
EGFR Mutant Non-Small Cell Lung Cancer

Eligibility: Registered to the A151216 lung cancer screening trial with EGFR exon 19 deletion or L858R mutation; EGFR TK domain (T790M are NOT eligible); Can register if have both EGFR mutant and ALK rearrangements; Completely resected stage IB (> 4 cm), II or IIIA non-squamous NSCLC with negative margins; Recovered post–op and completed standard post-op therapy (if applicable); No interstitial fibrosis or lung disease; PS 0-1.
RX: Erlotinib versus Placebo (Erlotinib/Placebo SUPPLIED)

3. ECOG-ACRIN E4512 / NCT02201992
ALK Gene Rearrangement Non-Small Cell Lung Cancer

Eligibility: Registered to the A151216 lung cancer screening trial and positive for translocation or inversion events involving the ALK gene locus (e.g. EML4-ALK fusion); Completely resected stage IB (> 4 cm), II or IIIA NSCLC with negative margins (N3 disease not allowed); No interstitial fibrosis or interstitial lung disease; PS 0-1; Recovered post–op and completed standard post-op therapy (if applicable).
RX: Crizotinib versus Placebo (Crizotinib/Placebo SUPPLIED)

4. ECOG-ACRIN EA5142 / NCT02595944
Adjuvant Treatment in Resected Lung Cancers (ANVIL)

Eligibility: Age > 18 y/o; Complete surgical resection of stage IB (> 4 cm), II or IIIA NSCLC; No evidence or disease and no mets; Must be registered to ALCHEMIST-SCREEN (A151216) trial prior to randomization (Non-squamous tumors must be EGFR and ALK wild-type and PD-L1 status tested); No prior treatment with an immune checkpoint inhibitor; No autoimmune diseases; PS 0-1.
RX: Nivolumab q 2 wks x 1 year versus Observation per standard of care.
(NIVOLUMAB SUPPLIED)

Lung Protocols: Small Cell

1. CALGB 30610 (RTOG 0538) / NCT00632853 (QOL closed eff: 8/30/17)
Limited Stage - Small Cell Lung Cancer

Eligibility: Pathologically documented Small Cell Lung CA; No prior surgical resection; Restricted to one hemithorax; No pleural effusions; Must have measurable disease > 2 cm (or > 1 cm spiral CT); only 1 prior cycle of Cisplatin and Etoposide allowed (but all pre-study tests must be done before); no prior RT; PS = 0-2.
RX: Cisplatin + Etoposide x 4 cycles w/RT for 3 weeks versus Cisplatin + Etoposide x 4 cycles w/RT for 7 weeks. (NO DRUGS SUPPLIED)

Melanoma

1. SWOG S1320 / NCT02196181
BRAF Mutation-Positive (V600E or V600K) Melanoma

Eligibility: Histological Stage IV or unresectable Stage III BRAF mutation positive (V600E or V600K) mutant melanoma; Must have measurable disease; No prior BRAF or MEK inhibitor; If brain mets, must have been treated and asymptomatic; No unresolved toxicity greater than a grade 1; PS 0-1; No GI function impairments; Must be able to take oral medications; No evidence of retinal vein occlusion or central serous retinopathy.
RX: Step 1: Dabrafenib + Trametinib (continuous 8 wk lead-in). If no disease progression →
Step 2: (continuous) Dabrafenib + Trametinib versus (intermittent) Dabrafenib + Trametinib
(DABRAFENIB and TRAMETINIB SUPPLIED)

2.  SWOG S1512 / NCT02775851
Resectable or Unresectable Desmoplastic Melanoma

Eligibility: Age > 18; Histologically/cytologically confirmed primary desmoplastic melanoma: Cohort A: resectable or Cohort B: unresectable; Must have measurable disease per RECIST; No known brain mets unless they have been treated and pt is asymptomatic; Must not have received prior systemic treatment for this melanoma; No plans to receive concomitant other therapy while on this protocol; Patients may have received prior surgery; PS < 2.
RX: Refer to Cohort A (resectable disease) or Cohort B (unresectable disease):

Cohort A – MK-3475 x 3 cycles » Disease Assessment » If resectable: surgery (off treatment); If not resectable or progression: 1 cycle of MK-3475 » Disease Assessment » If resectable: surgery (Off treatment); If not resectable or progression: Off treatment.

Cohort B – Continuous treatment with MK-3475 » If becomes resectable, choice of: surgery or continue treatment with MK-3475. However, if progression: 1 cycle of MK-3475 » Disease Assessment: If progression, Off treatment; If no progression, continue treatment with MD-3475. 

(MK-3475 (pembrolizumab) SUPPLIED)

3. SWOG S1616 / NCT03033567
Unresectable Stage III or Metastatic Melanoma

Eligibility: Age > 18; Pathologically confirmed melanoma either Stage IV or unresectable Stage III; Uveal (ocular) primary are not eligible; Must have measurable disease; CNS mets must have all lesions adequately treated; Must have had prior treatment with anti-PD1 or anti-PD-L1 agents and documented disease progression (without achieving partial or complete response before progression); No prior treatment with ipilimumab or other CTLA-4 antagonists; No systemic therapy between progression on the anti-PD-1 or anti-PD-L1 agents and registration; PS 0-2.
RX: Ipilimumab x 4 cycles versus Ilpilimumab + Nivolumab x 4 cycles, followed by Nivolumab. (IPILIMUMAB and NIVOLUMAB SUPPLIED)

Multiple Myeloma

1.  Alliance A061402 / NCT02516423
Solitary Plasmacytoma of Bone

Eligibility: Pre-registration: Age > 18; Histologic documentation of solitary bone plamacytoma from a bone marrow aspirate and biopsy containing < 10% clonal plasma cells; May pre-register before start of xRT or after completion of xRT; Must have disease measurable by either serum or urine evaluation; PS 0-2; Registration: No lytic lesions on skeletal survey and whole body PET/CT other than single lesion associated with solitary bone plasmacytoma; Must have disease measurable by either serum or urine evaluation; Reg must be completed w/in 90 days of completion of xRT; PS 0-2; Dental evaluation w/in 35 days of registration.
RX: Pre-registration » Registration/Randomization: Ixazomib, Lenalidomide, Dexamethasone, Zolondronic Acid versus Zolendronic Acid.
(LENALIDOMIDE, IXAZOMIB SUPPLIED)

Miscellaneous

1. DCP-001
Screening Tool to Address Cancer Health Disparities in NCORP

Eligibility: All patients screened for NCORP and NCTN trials. (Trials include: symptom and toxicity management, prevention, screening, post-treatment surveillance, comparative effectiveness, late phase treatment trials and select cancer care delivery clinical trials). Patients consent to collecting baseline expanded demographic and clinical data AND to help understand patients that are screened but not enrolled AND patients that enroll to participate in NCI trials.
Assessment: Baseline collection of expanded demographic and screening data
(NO DRUG SUPPLIED)

2. ECOG-ACRIN EAY131 (NCI MATCH) / NCT02465060
Molecular Analysis for Therapy Choice (MATCH)
Eligibility: Age > 18; Histologically documented solid tumors or confirmed diagnosis of systemic therapy and/or for whose disease no standard treatment exists to show prolong survival; Must have measurable disease; Must have tumor amenable to image guided or direct vision biopsy or have formalin-fixed paraffin-embedded tumor tissue block available w/in 6 months for molecular profiling from designated outside laboratories; Designated outside lab will indicate and notify sites if a “rare variant” with an actionable mutation of interest (aMOI) matches a specific subprotocol and may be a potential candidate;  PS 0-1; No concurrent investigational agents.
Molecular Profiling and RX:

  • Subprotocol A (EGFR activating mutation) RX: Afatinib
  • Subprotocol B (HER2 activating mutation) RX: Afatinib
  • Subprotocol C1 (MET amplification) RX: Crizotinib
  • Subprotocol C2 (MET exon 14 deletion) RX: Crizotinib
  • Subprotocol E (EGFR T790M or rare activating mutation) RX: Osimertinib
  • Subprotocol F (ALK translocation) RX: Crizotinib
  • Subprotocol G (ROS1 translocation or inversion) RX: Crizotinib
  • Subprotocol H (BRAF V600E/R/K/D mutation) RX: Dabrafenib
  • Subprotocol I (PIK3CA mutation or amplification) RX: Taselisib

    (Closed to accrual eff: 4/21/17)

  • Subprotocol J (HER2 amplification > 7 copies) RX: Pertuzumab + Trastuzumab Emtansine
  • Subprotocol L (mTOR mutation) RX: Sapanisertib
  • Subprotocol M (TSC1 or TSC2 mutation) RX: Sapanisertib
  • Subprotocol N (PTEN mutation or deletion and PTEN expression) RX: PI3K-beta Inhibitor GSK2636771 (Temporary closed eff: 11/16/16)
  • Subprotocol P (PTEN loss) RX: PI3K-beta Inhibitor GSK2636771 (Closed to accrual eff: 2/21/17)
  • Subprotocol Q (HER2 amplification) RX: Trastuzumab Emtansine (Closed to accrual eff: 3/13/17)
  • Subprotocol R (BRAF fusion or BRAF non-V600 mutation) RX: Trametinib (Suspended to accrual eff: 8/22/17)
  • Subprotocol S1 (NF1 mutation) RX: Trametinib (Suspended to accrual eff: 9/13/17)
  • Subprotocol S2 (GNAQ or GNA11 mutation) RX: Trametinib
  • Subprotocol T (SMO or PTCH1 mutation) RX: Vismodegib
  • Subprotocol U (NF2 inactivating mutation) RX: Defactinib
  • Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation) RX: Sunitinib Malate
  • Subprotocol W (FGFR pathway aberrations) RX: FGFR Inhibitor AZD4547
  • Subprotocol X (DDR2 S768R, I638F, or L239R mutation) RX: Dasatinib
  • Subprotocol Y (Akt mutation) RX: AZD5363 (Suspended to accrual eff: 8/4/17)
  • Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61) RX: Binimetinib (Suspended to accrual eff: 7/24/17)
  • Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC) RX: Palbociclib
  • Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein) RX: Palbociclib
  • Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC) RX: Nivolumab (Suspended to accrual eff: 8/14/17)
  • Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion) RX: Trk Inhibitor LOXO-101
  • Subprotocol Z1I (BRCA1 or BRCA2 gene mutation) RX: WEE1 Inhibitor AZD1775

(DRUGS SUPPLIED)

4. SWOG S1609 (DART) / NCT02834013
Combinatorial Immune Checkpoint Blockade for Specific Rare Tumors

Eligibility: Age > 18; Histologically confirmed rare cancer identified in Protocol Section 18.1 to be eligible; Must have progressed following at least one line of standard systemic therapy and no other approved/standard therapy available to prolong overall survival; Measurable disease; May have received either prior anti-CTLA4 or other prior anti-PD-1/anti-PD-L1, not both; PS 0-2.
RX: Ipilumumab + Nivolumab (IPILUMUMAB and NIVOLUMAB SUPPLIED)

Eligible Rare Cancer Cohorts for S1609 (DART):

  1. Epithelial tumors or nasal cavity, sinuses, nasopharynx
  2. Epithelial tumors of major salivary glands
  3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (Temporary closure to accrual eff: 5/26/17).
  4. Undifferentiated carcinoma of GI tract
  5. Adenocarcinoma with variants of small intestine
  6. Squamous cell carcinoma with variants of GI tract
  7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (Temporary closure to accrual eff: 7/24/17).
  8. Rare pancreatic tumors including acinar cell carcinoma, mucinous and serous cystadenocarcinomas. Pancreatic adenocarcinomas is not eligible.
  9. Intrahepatic Cholangiocarcinoma (Temporary closure to accrual eff: 6/15/17).
  10. Cholangiocarcinoma and extrahepatic bile duct tumors (Temporary closure to accrual eff: 7/24/17).
  11. Sarcomatoid carcinoma of lung
  12. Bronchoalveolar carcinoma of lung
  13. Non-epithelial tumors of the ovary (Germ cell tumor of ovary; Mullerian mixed tumor and adenosarcoma)
  14. Trophoblastic tumor (Choriocarcinoma)
  15. Transitional cell carcinoma other than renal pelvis ureteral or bladder
  16. Cell tumor of the testes and extragonadal germ tumors (Seminoma and testicular sex cord cancer; Non seminomatous tumor; Teratoma with malignant transformation)
  17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis
  18. Squamous cell carcinoma variants of the genitourinary (GU) system
  19. Spindle cell carcinoma of kidney, pelvis, ureter
  20. Adenocarcinoma with variants of GU system (excluding prostate cancer)
  21. Odontogenic malignant tumors
  22. Endocrine carcinoma of pancreas and digestive tract
  23. Neuroendocrine carcinoma including carcinoid of the lung
  24. Pheochromocytoma, malignant
  25. Paraganglioma
  26. Carcinomas of pituitary gland, thyroid gland, parathyroid gland and adrenal cortex
  27. Desmoid tumors
  28. Peripheral nerve sheath tumors and NF1-related tumors
  29. Malignant giant cell tumors
  30. Chordoma
  31. Adrenal cortical tumors
  32. Tumor of unknown primary (Cancer of Unknown Primary; CuP)
  33. Not Otherwise Categorized (NOC) Rare Tumors, after discussion with Study Chairs.

These Protocols are Approved for use at the Following Hospitals & Clinics

  • Alta Bates Summit Medical Center – Summit Campus
  • Bay Area Breast Surgeons
  • Bay Area Tumor Institute
  • Children’s Hospital Research Center Oakland (contact: 510-428-3372 for pediatric trials)
  • Contra Costa Regional Medical Center
  • Epic Care Dublin
  • Epic Care Partners in Cancer Care – Emeryville

Abbreviations

  • ACOSOG = American College of Surgeons Oncology Group
  • ACRIN = American College of Radiology Imaging Network
  • Alliance = Alliance for Clinical Trials in Oncology = Consolidation of ACOSOG-CALGB-NCCTG Cancer Research Groups
  • CALGB = Cancer and Leukemia Group B
  • CCCWFU = Comprehensive Cancer Center at Wake Forest University
  • COG = Children’s Oncology Group
  • CTSU = Cancer Trials Support Unit
  • ECOG = Eastern Cooperative Oncology Group
  • ECOG-ACRIN = Consolidation of ECOG-ACRIN Cancer Research Groups
  • GOG = Gynecologic Oncology Group
  • IBCSG = International Breast Cancer Study Group
  • NCI = National Cancer Institute
  • NCCTG = The North Central Cancer Treatment Group
  • NCORP = NCI Community Oncology Research Program
  • NRG Oncology = Consolidation of NSABP-RTOG-GOG Cancer Research Groups
  • NSABP = National Surgical Adjunct Breast and Bowel Project
  • PACCT = Program for the Assessment of Clinical Cancer Tests
  • RTOG = Radiation Therapy Oncology Group
  • SCUSF = SunCoast CCOP Research Base
  • SWOG = Southwest Oncology Group

REVISED 10/13/17