Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

Summary

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

Timeline

Start

2022-12-08

Primary completion

2026-09-30

Completion

2033-09-30

Publications

• Raman S, Khalil MA, Eisenstein S, Lin M. Selected Abstracts. Dis Colon Rectum. 2026 Jul 1;69(7):1938-1942. doi: 10.1097/DCR.0000000000004250. Epub 2026 Apr 7. No abstract available.
• Scott AJ, Kennedy EB, Berlin J, Brown G, Chalabi M, Cho MT, Cusnir M, Dorth J, George M, Kachnic LA, Kennecke HF, Loree JM, Morris VK, Perez RO, Smith JJ, Strickland MR, Gholami S. Management of Locally Advanced Rectal Cancer: ASCO Guideline. J Clin Oncol. 2024 Oct;42(28):3355-3375. doi: 10.1200/JCO.24.01160. Epub 2024 Aug 8.
• Alvarez JA, Shi Q, Dasari A, Garcia-Aguilar J, Sanoff H, George TJ, Hong T, Yothers G, Philip P, Nelson G, Al Baghdadi T, Alese OB, Zambare W, Omer D, Verheij FS, Bercz A, Kim MJ, Buckley J, Williams H, George M, Garcia R, Gallagher P, O'Reilly EM, Meyerhardt JA, Crawley J, Shergill A, Horvat N, Romesser PB, Hall W, Smith JJ. Alliance A022104/NRG-GI010: The Janus Rectal Cancer Trial: a randomized phase II/III trial testing the efficacy of triplet versus doublet chemotherapy regarding clinical complete response and disease-free survival in patients with locally advanced rectal cancer. BMC Cancer. 2024 Jul 26;24(1):901. doi: 10.1186/s12885-024-12529-7.
• Alvarez J, Shi Q, Dasari A, Garcia-Aguilar J, Sanoff H, George TJ, Hong TS, Yothers G, Philip PA, Nelson GD, Al Baghdadi T, Alese O, Zambare W, Omer DM, Verheij FS, Buckley J, Williams H, George M, Garcia R, O'Reilly EM, Meyerhardt JA, Shergill A, Horvat N, Romesser PB, Hall WA, Smith JJ. ALLIANCE A022104/NRG-GI010: The Janus Rectal Cancer Trial: a randomized phase II/III trial testing the efficacy of triplet versus doublet chemotherapy regarding clinical complete response and disease-free survival in patients with locally advanced rectal cancer. medRxiv [Preprint]. 2024 Apr 27:2024.04.25.24306396. doi: 10.1101/2024.04.25.24306396.
• Langenfeld SJ, Davis BR, Vogel JD, Davids JS, Temple LKF, Cologne KG, Hendren S, Hunt S, Garcia Aguilar J, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Rectal Cancer 2023 Supplement. Dis Colon Rectum. 2024 Jan 1;67(1):18-31. doi: 10.1097/DCR.0000000000003057. Epub 2023 Aug 20. No abstract available.

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Indications