A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

December 1, 2020

Primary Completion Date

December 1, 2022

Study Completion Date

December 1, 2025

Conditions
Rectal Cancer
Interventions
COMBINATION_PRODUCT

Concurrent Chemoradiotherapy Radiotherapy

50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.

RADIATION

Short-course Radiotherapy

25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.

RADIATION

Local dose increase of Short-course Radiotherapy

25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.

DRUG

Consolidation chemotherapy

Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses\*3 weeks per course.

DRUG

Adjuvant chemotherapy

2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses\*3 weeks per course

PROCEDURE

TME

Total mesorectal excision

Trial Locations (1)

100021

RECRUITING

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing

All Listed Sponsors
lead

Jing Jin, M.D.

UNKNOWN