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A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer

NCT05939661 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-07-11

No results posted yet for this study

Summary

A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer

Conditions

Interventions

RADIATION

Radiation

Neoadjuvant radiation therapy : 5Gyx5

DRUG

Chemotherapy

CAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles

PROCEDURE

Surgery

Operation: Total methorectum excision wiht radical lymph node dissection

Sponsors & Collaborators

  • Osaka University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2026-03-31
Completion
2030-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT05939661 on ClinicalTrials.gov