drugset / Trial / NCT04370925

Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

NCT04370925

Phase 3 Unknown 688 enrolled Affiliated Cancer Hospital & Institute of Guangzhou Medical University Beijing Hospital · collabCancer Institute and Hospital, Chinese Academy of Medical Sciences · collabChongqing University Cancer Hospital · collabFirst Affiliated Hospital of Chongqing Medical University · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabFirst People's Hospital of Foshan · collabFudan University · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabGuangdong Provincial People's Hospital · collabHebei Medical University Fourth Hospital · collabJiangmen Central Hospital · collabMeizhou People's Hospital · collabNanfang Hospital, Southern Medical University · collabPeking University Cancer Hospital & Institute · collabPeking University People's Hospital · collabPeople's Hospital of Deyang City · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabRenmin Hospital of Wuhan University · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabShantou Central Hospital · collabShenzhen Second People's Hospital · collabSichuan Provincial People's Hospital · collabSixth Affiliated Hospital, Sun Yat-sen University · collabSun Yat-sen University · collabThe Affiliated Hospital Of Southwest Medical University · collabThe Affiliated Hospital of Xuzhou Medical University · collabThe Affiliated Tumor Hospital of Guangxi Medical University · collabThe First Affiliated Hospital of Nanchang University · collabThe People's Hospital of Leshan · collabThe Second Affiliated Hospital of Chongqing Medical University · collabThe Third People's Hospital of Chengdu · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWest China Hospital · collabWuhan University · collabZhongshan People's Hospital, Guangdong, China · collabZhuHai Hospital · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the efficacy of adjuvant HIPEC with Mitomycin C after colectomy in the treatment of colorectal cancer patients at high risk of peritoneal carcinomatosis.

Timeline

Start
2020-06-04
Primary completion
2024-04-30
Completion
2026-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 30 mg/m2 Other
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications