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

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.

NCT Number	NCT03975049
Lead Sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Conditions	Rectal Cancer, Chemotherapy Effect
Enrollment	933 participants
Start Date	2019-08
Primary Completion	2024-07 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2019-06-05