Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer (JCOG1801)
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: Japan Agency for Medical Research and Development
A PHASE3 clinical study on Rectal Cancer Recurrent, this trial is actively recruiting participants. The trial is conducted by Japan Agency for Medical Research and Development and has accumulated 7 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Recruiting PHASE3
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Sep 2025 — Present [monthly]
Recruiting PHASE3
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Sep 2024 — Sep 2025 [monthly]
Recruiting PHASE3
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jan 2021 — Jul 2024 [monthly]
Recruiting PHASE3
▶ Show 2 earlier versions
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Jul 2020 — Jan 2021 [monthly]
Recruiting PHASE3
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Mar 2020 — Jul 2020 [monthly]
Recruiting PHASE3
First recorded
Oct 2019
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Japan Agency for Medical Research and Development
- Japan Clinical Oncology Group
- National Cancer Center Hospital East
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Chiba, Japan , Gifu, Japan , Hidaka, Japan , Hirakata, Japan , Hiroshima, Japan , Izumo, Japan , Kanazawa, Japan , Kashiwa, Japan , Kawagoe, Japan , Kochi, Japan and 25 more locations