drugset / Trial / NCT03975049

Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT03975049 ↗

Phase 3 Not yet recruiting 933 enrolled Sixth Affiliated Hospital, Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

Preoperative radiation with single agent chemotherapy as sensitizer is the standard care of locally advanced rectal cancer. Local irradiation significantly increases surgical complications and impairs quality of life. Combination chemotherapy alone seems promising and provides similar benefit to chemoradiation as neoadjuvant therapy. Early administration of systemic therapy is also proved beneficial for long-term survival. The purpose of this study is to compare the efficacy of chemotherapy alone with short-term modified FOLFOXIRI or long-term mFOLFOX with standard chemoradiation as neoadjuvant therapy for locally advanced rectal cancer.

Timeline

Start
2019-08
Primary completion
2024-07
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 150 mg/m2 —
Subject Leucovorin Small molecule 400 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications