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RECRUITING
NCT05939661
PHASE2

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

Sponsor: Osaka University

View on ClinicalTrials.gov

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2023-05-25

Completion Date

2030-03-31

Last Updated

2023-07-11

Healthy Volunteers

No

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

Locations (2)

Osaka General Medical Center

Osaka, Japan

Osaka University Hospital

Osaka, Japan