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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

933

Participants

Timeline

Start Date

August 31, 2019

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2029

Conditions
Rectal CancerChemotherapy Effect
Interventions
RADIATION

Chemoradiation

Fluorouracil 225 mg/m2/day continuous intravenous infusion on weekdays for five weeks; local irradiation 2GY/day on weekdays, totally 50GY.

DRUG

FOLFOXIRI Protocol

Oxaliplatin 85 mg/m2 on day 1; irinotecan 150 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days; prophylactic G-CSF support is recommended.

DRUG

Folfox Protocol

Oxaliplatin 85 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 400 mg/m2 bolus and 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days.

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER