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.
In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions), and quality of life after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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
Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)
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
Time frame: 3-years after registration
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
Time frame: 3-years after registration
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
Time frame: 3-years after registration
Local relapse rate
Proportion of local relapse
Time frame: 3-years after registration
Distant relapse rate
Proportion of distant relapse
Time frame: 3-years after registration
R0 resection rate
Proportion of patients with pathological R0 resection
Time frame: 1 month after surgery
Response rate of preoperative chemoradiotherapy (preCRT)
Response rate of preCRT (arm B)
Time frame: before surgery
Pathological complete response rate
Pathological complete response rate (arm B)
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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
Chiba Cancer Center
Chiba, Japan
RECRUITINGGifu University School of Medicine
Gifu, Japan
RECRUITINGSaitama Medical University International Medical Center
Hidaka, Japan
NOT_YET_RECRUITINGKansai Medical University Hospital
Hirakata, Japan
NOT_YET_RECRUITINGHiroshima City Asa Citizens Hospital
Hiroshima, Japan
RECRUITINGHiroshima City Hospital
Hiroshima, Japan
RECRUITINGShimane University Faculty of Medicine
Izumo, Japan
RECRUITINGIshikawa Prefectural Central Hospital
Kanazawa, Japan
RECRUITINGNational Cancer Center Hospital East
Kashiwa, Japan
RECRUITINGSaitama Medical Center, Saitama Medical University
Kawagoe, Japan
RECRUITING...and 35 more locations
Time frame: 1 month after surgery
Completeness of the protocol treatment
Proportion of patients who completed the protocol treatment
Time frame: 8 months after surgery
Adverse event rate
Incidence of adverse events (adverse reactions)
Time frame: 3-years after surgery registration
QOL
QOL after surgery based on the Trial Outcome Index-Physical/Functional/Colorectal (TOI-PFC) \[0(better)-84(worse)\]
Time frame: 3-years after registration