{"preliminary_commentary":{"by_channel":{"x_thread":23,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02921256\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["veliparib"],["pembrolizumab"]],"indication":"locally advanced rectal adenocarcinoma","name":"NRG-GI002","nct_id":"NCT02921256","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nrg-gi002-nct02921256. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Participants assigned to Arm I concurrently with Arm II or with Arm III.","label":"Arm I (mFOLFOX6, RT, capecitabine)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity.","label":"Arm II (mFOLFOX6, RT, capecitabine, veliparib)","type":"EXPERIMENTAL"},{"description":"ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity.","label":"Arm III (mFOLFOX6, RT, capecitabine, pembrolizumab)","type":"EXPERIMENTAL"}],"collaborators":["NRG Oncology"],"completion_date":{"date":"2023-09-20","type":"ACTUAL"},"conditions":["Rectal Adenocarcinoma","Stage II Rectal Cancer AJCC v7","Stage III Rectal Cancer AJCC v7"],"enrollment":{"count":363,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Capecitabine","otherNames":["Ro 09-1978/000","Xeloda"],"type":"DRUG"},{"name":"Fluorouracil","otherNames":["5 Fluorouracil","5 Fluorouracilum","5 FU","5-Fluoro-2,4(1H, 3H)-pyrimidinedione","5-Fluorouracil","5-Fluracil","5-Fu","5FU","AccuSite","Carac","Fluoro Uracil","Fluouracil","Flurablastin","Fluracedyl","Fluracil","Fluril","Fluroblastin","Ribofluor","Ro 2-9757","Ro-2-9757"],"type":"DRUG"},{"name":"Intensity-Modulated Radiation Therapy","otherNames":["IMRT","Intensity modulated radiation therapy (procedure)","Intensity Modulated RT","Intensity-Modulated Radiotherapy","Radiation, Intensity-Modulated Radiotherapy"],"type":"RADIATION"},{"name":"Leucovorin","otherNames":["Folinic acid"],"type":"DRUG"},{"name":"Oxaliplatin","otherNames":["1-OHP","Ai Heng","Aiheng","Dacotin","Dacplat","Diaminocyclohexane Oxalatoplatinum","Eloxatin","Eloxatine","JM-83","Oxalatoplatin","Oxalatoplatinum","RP 54780","RP-54780","SR-96669"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["BCD-201","Keytruda","Lambrolizumab","MK-3475","Pembrolizumab Biosimilar BCD-201","SCH 900475"],"type":"BIOLOGICAL"},{"name":"Veliparib","otherNames":["ABT-888","PARP-1 inhibitor ABT-888"],"type":"DRUG"}],"last_update":"2025-12-04","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2020-04-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Neoadjuvant Rectal Cancer (NAR) Score","timeFrame":"Baseline to up to 3 years"}],"references":[{"citation":"Hall WA, Li J, You YN, Gollub MJ, Grajo JR, Rosen M, dePrisco G, Yothers G, Dorth JA, Rahma OE, Russell MM, Gross HM, Jacobs SA, Faller BA, George S, Al Baghdadi T, Haddock MG, Valicenti R, Hong TS, George TJ. Prospective Correlation of Magnetic Resonance Tumor Regression Grade With Pathologic Outcomes in Total Neoadjuvant Therapy for Rectal Adenocarcinoma. J Clin Oncol. 2023 Oct 10;41(29):4643-4651. doi: 10.1200/JCO.22.02525. Epub 2023 Jul 21.","pmid":"37478389","type":"DERIVED"},{"citation":"Rahma OE, Yothers G, Hong TS, Russell MM, You YN, Parker W, Jacobs SA, Colangelo LH, Lucas PC, Gollub MJ, Hall WA, Kachnic LA, Vijayvergia N, O'Rourke MA, Faller BA, Valicenti RK, Schefter TE, George S, Kainthla R, Stella PJ, Sigurdson E, Wolmark N, George TJ. Use of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Initial Results From the Pembrolizumab Arm of a Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1225-1230. doi: 10.1001/jamaoncol.2021.1683.","pmid":"34196693","type":"DERIVED"}],"start_date":{"date":"2017-01-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer","url":"https://clinicaltrials.gov/study/NCT02921256"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nrg-gi002-nct02921256"}