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

NCT04664504 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-06-08

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • Jing Jin, M.D.

    lead UNKNOWN

Principal Investigators

  • Yuan Tang, M.D. · Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-01
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664504 on ClinicalTrials.gov