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TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer

NCT05646511 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2025-04-03

No results posted yet for this study

Summary

This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

RADIATION

SCRT

5x5 Gy: 25 Gy

DRUG

CAPOX

Six cycles of CAPOX capecitabine 1000 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1, every 3 weeks

DRUG

CAPOXIRI

Six cycles of CAPOXIRI capecitabine 800 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1 and irinotecan 150 mg/m2 intravenously on day 1, every 3 weeks

Sponsors & Collaborators

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • National Cancer Center Hospital East

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Japan

Study Locations

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Entities

Drugs

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 NCT05646511 on ClinicalTrials.gov