TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer

Phase 3 Recruiting 608 enrolled National Cancer Center Hospital East Japan Agency for Medical Research and Development · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.

Timeline

Start: 2022-11-21
Primary completion: 2029-12-31
Completion: 2030-12-31

Publications

Background Watanabe J, Kagawa Y, Chida K, Ando K, Kotani D, Oba K, Bando H, Hojo H, Shimamoto S, Sakashita S, Kuwata T, Tsuboyama T, Hosomi N, Uemura M, Uehara K, Ito M, Oki E, Takemasa I, Misugi E, Sledge G, Sumani K, Imoto S, Kato T, Yoshino T. Phase III trial of short-course radiotherapy followed by CAPOXIRI versus CAPOX in locally advanced rectal cancer: the ENSEMBLE trial. ESMO Gastrointest Oncol. 2023 Nov 7;1:9-14. doi: 10.1016/j.esmogo.2023.08.002. eCollection 2023 Oct.
Background Kagawa Y, Smith JJ, Fokas E, Watanabe J, Cercek A, Greten FR, Bando H, Shi Q, Garcia-Aguilar J, Romesser PB, Horvat N, Sanoff H, Hall W, Kato T, Rodel C, Dasari A, Yoshino T. Future direction of total neoadjuvant therapy for locally advanced rectal cancer. Nat Rev Gastroenterol Hepatol. 2024 Jun;21(6):444-455. doi: 10.1038/s41575-024-00900-9. Epub 2024 Mar 14.
Background 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.
Background Kagawa Y, Watanabe J, Uemura M, Ando K, Inoue A, Oba K, Takemasa I, Oki E. Short-term outcomes of a prospective multicenter phase II trial of total neoadjuvant therapy for locally advanced rectal cancer in Japan (ENSEMBLE-1). Ann Gastroenterol Surg. 2023 Jul 11;7(6):968-976. doi: 10.1002/ags3.12715. eCollection 2023 Nov.
Background Kagawa Y, Ando K, Uemura M, Watanabe J, Oba K, Emi Y, Matsuhashi N, Izawa N, Muto O, Kinjo T, Takemasa I, Oki E. Phase II study of long-course chemoradiotherapy followed by consolidation chemotherapy as total neoadjuvant therapy in locally advanced rectal cancer in Japan: ENSEMBLE-2. Ann Gastroenterol Surg. 2024 Aug 3;8(6):1067-1075. doi: 10.1002/ags3.12848. eCollection 2024 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	800 mg/m2	Oral
Comparator	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Irinotecan	Small molecule	150 mg/m2	Intravenous
Comparator	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

Indications

No indication recorded.