Effect of Concurrent Capecitabine-based Long-term Radiotherapy Followed by XELOX Plus TME in Patients With High Risk Rectal Cancer: a Multi-centers, Randomized Controlled, Open-Label Trial

Summary

The purpose of this study was to evaluate the effect of concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles XELOX post- a Regular Timing TME in patients with high-risk rectal cancer defined by MRI.

Conditions

• Rectal Cancer
• Pathological Complete Response
• Disease Free Survival

Interventions

DRUG

concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME

concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted. XELOX: Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks Surgery Procedure: Total Mesorectal Excision

DRUG

concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX

concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted. XELOX: Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks Surgery Procedure: Total Mesorectal Excision

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Affiliated Hospital of Hebei University

  collaborator OTHER

• Peking University People's Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-31

Primary Completion

2023-04-01

Completion

2025-06-01

Countries

• China

Study Locations