drugset

drugset / Trial / NCT04922853

Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer

NCT04922853 ↗

Phase 3 Active not recruiting 554 enrolled West China Hospital Chengdu Fifth People's Hospital · collab Dazhou Central Hospital · collab GeneCast Biotechnology Co., Ltd. · collab Leshan People's Hospital · collab Nanchong Central Hospital · collab Peking Union Medical College · collab Peking University Cancer Hospital & Institute · collab Second Affiliated Hospital, School of Medicine, Zhejiang University · collab Sichuan Provincial People's Hospital · collab Sun Yat-Sen University Cancer Center · collab The Affiliated Hospital Of Guizhou Medical University · collab The First Affiliated Hospital of Zhengzhou University · collab The Third People's Hospital of Chengdu · collab Yunnan Cancer Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer.

Timeline

Start: 2021-08-26
Primary completion: 2024-10-01
Completion: 2027-12-01

Publications

Shen Y, Shi W, Huang C, Gong X, Wei M, Meng W, Deng X, Wang Z; COPEC groups. Comparison of the pathological response to 2 or 4 cycles of neoadjuvant CAPOX in II/III rectal cancer patients with low/intermediate risks: study protocol for a prospective, non-inferior, randomized control trial (COPEC trial). Trials. 2023 Jun 13;24(1):397. doi: 10.1186/s13063-023-07405-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

Indications