RecruitingPhase 3NCT05646511

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

A Multicenter Randomized Phase III Study of Short-term Radiotherapy Plus CAPOX and Short-term Radiotherapy Plus CAPOXIRI as Preoperative Treatment for Locally Advanced Rectal Cancer

Sponsor

National Cancer Center Hospital East

Enrollment

608 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy regimens given after short-course radiation for people with locally advanced rectal cancer. It tests whether adding an extra chemotherapy drug (irinotecan) to the standard treatment improves outcomes before surgery. **You may be eligible if...** - You have been diagnosed with rectal cancer (confirmed by biopsy) - Your cancer has not spread to other organs - You are 18 or older and in good enough health to tolerate chemotherapy - Your cancer appears removable with surgery **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have severe heart, liver, or kidney problems - You have had prior treatment for this rectal cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSCRT

5x5 Gy: 25 Gy

DRUGCAPOX

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

DRUGCAPOXIRI

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

Locations(34)

National Cancer Center Hospital East

Chiba, Japan

Ehime Prefectural Central Hospital

Ehime, Japan

Kyushu University Hospital

Fukuoka, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Gifu University Hospital

Gifu, Japan

Hirosaki University Hospital

Hirosaki, Japan

Hiroshima University Hospital

Hiroshima, Japan

St. Marianna University Hospital

Kawasaki, Japan

University of Occupational and Environmental Health Hospital

Kitakyushu, Japan

Kochi Medical School Hospital

Kochi, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kyoto Prefectural University of Medicine

Kyoto, Japan

Nagoya University Hospital

Nagoya, Japan

Ohara Memorial Kurashiki Central Medical Organization Kurashiki Central Hospital

Okayama, Japan

Okayama University Hospital

Okayama, Japan

Kansai Medical University Hospital

Osaka, Japan

Kindai University Hospital

Osaka, Japan

National Hospital Organization Osaka Medical Center

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Osaka Prefectural Hospital Organization Osaka Acute and General Medical Center

Osaka, Japan

Osaka University Hospital

Osaka, Japan

Kitasato University Hospital

Sagamihara, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Keio University Hospital

Tokyo, Japan

National Cancer Center Hospital

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Komagome Hospital

Tokyo, Japan

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Japan

Yokohama City University Hospital

Yokohama, Japan

Yokohama City University Medical Center

Yokohama, Japan

Federation of National Public Service Personnel Mutual Aid Associations Yokosuka Mutual Aid Hospital

Yokosuka, Japan

View Full Details on ClinicalTrials.gov

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NCT05646511

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