drugset / Trial / NCT03161574

FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for Circumferential Radial Margin (CRM) Positive Rectal Cancer

NCT03161574 ↗

Phase 2 Withdrawn Guangxi Medical University
NaSingle-groupOpen-labelTreatment

Summary

Neoadjuvant 5-Fu based chemoradiation followed by surgery is a standard treatment for locally advanced rectal cancer. However, radiation-related side effects could not be neglected. But this multimodality strategy failed to improve survival. Neoadjuvant chemotherapy alone may be an alternative strategy to minimize treatment-related toxicities without compromising the oncology outcome. Thus, patients with MRI-defined CRM-positive rectal cancer will receive 6 cycles of neoadjuvant treatment with FOLFOXIRI followed by surgery. The purpose of the study is to evaluate the efficacy of FOLFOXIRI alone as neoadjuvant treatment in treating patients with locally advanced rectal cancer.

Timeline

Start
2017-08-11
Primary completion
2019-12-01
Completion
2022-06-01

Outcome

Outcome not reported

Stopped (Enrollment): “No participants were recruited”

Drugs

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

Indications