drugset / Trial / NCT02942563

Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT02942563 ↗

Phase 2 Unknown 100 enrolled RenJi Hospital
NaSingle-groupOpen-labelTreatment

Summary

The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological complete response (pCR), which was associated with overall survival (OS). Here, the investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation and to improve the ratio of pCR further.

Timeline

Start
2016-11-01
Primary completion
2019-09-30
Completion
2022-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 625 mg/m2 Oral
Subject Irinotecan Small molecule 165 mg/m2 —
Subject Leucovorin Small molecule 200 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject Oxaliplatin Small molecule 135 mg/m2 —
Subject fluorouracil Small molecule 2800 mg/m2 —

Indications