Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation

PHASE3RecruitingINTERVENTIONAL
Enrollment

776

Participants

Timeline

Start Date

November 16, 2018

Primary Completion Date

September 25, 2025

Study Completion Date

September 25, 2028

Conditions
Rectal Cancer
Interventions
DRUG

FOLFOXIRI

Irinotecan165 mg/m2、Oxaliplatin85 mg/m2、Left-calcium leucovorin 200mg/㎡,Intravenous infusion,first day. Then, 5-FU 1600 mg/m2/d×2 continuous intravenous infusion(total 3200 mg/m2,infusion 46 hours)in the next two days. Repeat every 14 days.

DRUG

XELOX

XELOX consisting of 130 mg/m2 oxaliplatin administered intravenously on day 1 and 1,000 mg/m2 capecitabine administered orally twice daily on days 1-14 for a 3-week cycle.

OTHER

Chemoradiotherapy

"Chemotherapy: oral capecitabine(1650 mg/m2)twice daily during radiotherapy without weekend breaks.~Radiation: Radiation therapy is administered via intensity-modulated radiation therapy (IMRT) with a linear accelerator, 6MV-X ray. The patients are scheduled to receive a GTV expanding 6mm to form PTV1 and CTV expanding 6mm to form PTV2. The dose of PTV1 is 50Gy/25 times for 35 days and the dose of PTV2 is 45Gy/25 times for 35 days. Patients were treated in consecutive days per week for a total of 5 weeks."

PROCEDURE

TME operation

TME operation

PROCEDURE

efficacy evaluation

chest/ abdominal CT、pelvic nuclear magnetic resonanceimaging、transrectal ultrasonography

Trial Locations (2)

510060

RECRUITING

Cancer center of Sun Yat-sen University, Guangzhou

NOT_YET_RECRUITING

Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER