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.
Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer.
The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.
Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological diagnosis.
Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible.
Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
Infections requiring systemic treatment.
Body temperature higher than 38 degrees Celsius at registration.
Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.
Parallel
Chemotherapy
DrugAdjuvant 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
Preoperative radiotherapy
RadiationPreoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)
Procedure
Other interventionSurgery 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
Locally recurrent free survival
the period from registration in the trial to either the first event of local relapse or death from any cause and censored at the last date of contact for a living patient
Overall survival (OS)
s the time from registration to death from any cause and censored at the last date of contact for a living patient
Recurrence free survival (RFS)
the time from registration to either the first incidence of relapse or death from any cause and censored at the last date of contact for a living patient
Local relapse rate
Proportion of local relapse
Distant relapse rate
Proportion of distant relapse
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National Cancer Center Hospital East
Lead sponsor
Japan Clinical Oncology Group
Collaborator
Japan Agency for Medical Research and Development
Collaborator
