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RecruitingPhase 3NCT04288999

Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer

JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)

Sponsor

National Cancer Center Hospital East

Enrollment

110 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Recurrent

Summary

JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is for patients whose rectal cancer (cancer in the lower part of the large bowel) has come back in the same area after initial treatment. It compares two approaches: surgery plus chemotherapy alone, versus chemoradiation (combined chemotherapy and radiation) followed by surgery plus chemotherapy. The goal is to see which approach controls the cancer better. **You may be eligible if...** - Your initial rectal cancer has returned (locally recurrent) after prior surgery - Your original rectal cancer was pathologically confirmed as adenocarcinoma - Your original cancer was in the upper, middle, or lower rectum or anal canal - You received surgery for the original cancer with certain resection results **You may NOT be eligible if...** - Your recurrent cancer has spread to distant organs - You have conditions that make further surgery or radiation too risky - You did not have a previous rectal cancer resection 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

DRUGChemotherapy

Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours

RADIATIONPreoperative radiotherapy

Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)

OTHERProcedure

Surgery for Locally Recurrent Rectal Cancer (LRRC) will be performed within 42 days from registration for the patients in arm A, and between days 56 and 98 from the completion of the preCRT for the patients in arm B. Appropriate surgical procedure will be performed to achieve R0 resection, such as low anterior resection, super low anterior resection, intersphincteric resection, Hartmann procedure, rectal amputation, pelvic exenteration, tumor resection, or lateral lymph node dissection

Locations(45)

Chiba Cancer Center

Chiba, Japan

Gifu University School of Medicine

Gifu, Japan

Saitama Medical University International Medical Center

Hidaka, Japan

Kansai Medical University Hospital

Hirakata, Japan

Hiroshima City Asa Citizens Hospital

Hiroshima, Japan

Hiroshima City Hospital

Hiroshima, Japan

Shimane University Faculty of Medicine

Izumo, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Saitama Medical Center, Saitama Medical University

Kawagoe, Japan

Kochi Health Sciences Center

Kochi, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kurashiki Central Hospital

Kurashiki, Japan

Kurume University School of Medicine

Kurume, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Kyorin University Faculty of Medicine

Mitaka, Japan

Iwate Medical University

Morioka, Japan

Nagoya University Graduate School of Medicine

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Hyogo College of Medicine

Nishinomiya, Japan

Okayama Saiseikai General Hospital

Okayama, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Osaka City General Hospital

Osaka, Japan

Ogaki Municipal Hospital

Ōgaki, Japan

Gunma Prefectural Cancer Center

Ōta-ku, Japan

Saitama Cancer Center

Saitama, Japan

Sapporo-Kosei General Hospital

Sapporo, Japan

Miyagi Cancer Center

Sendai, Japan

Shizuoka Cancer Center

Shizuoka, Japan

Osaka University Graduate School of Medicine

Suita, Japan

Suita Municipal Hospital

Suita, Japan

Osaka Medical College

Takatsuki, Japan

National Defense Medical College

Tokorozawa, Japan

National Cancer Center Hospital

Tokyo, Japan

Toho University Ohashi Medical Center

Tokyo, Japan

Toho University Omori Medical Center

Tokyo, Japan

Tokyo Medical and Dental University Hospital

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo, Japan

Tochigi Cancer Center

Utsunomiya, Japan

Yamagata Prefectural Central Hospital

Yamagata, Japan

Kanagawa Cancer Center

Yokohama, Japan

Saiseikai Yokohama-shi Nanbu Hospital

Yokohama, Japan

Yokohama City University Medical Center

Yokohama, Japan

Oita University Faculty of Medicine

Yufu, Japan

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NCT04288999

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