At a glance
ClinicalIndex Comparison Record- ✓Histopathologically proven adenocarcinoma or adenosquamous carcinoma of initial rectal cancer
- ✓Initial rectal cancer treated with surgical or endoscopic resection classified as R0/1 or ER0/1
- ✓Recurrent rectal cancer diagnosed pathologically or by imaging modalities with chronological progression
- ✓LRRC resectable with no distant metastasis, positive circumferential resection margin, no leg amputation needed, first sacral nerve preservation possible
- ✕Synchronous or metachronous malignancies within 5 years except those with ≥95% 5-year survival rate
- ✕Infections requiring systemic treatment
- ✕Body temperature >38°C at registration
- ✕Pregnant, postpartum within 28 days, lactating, or male with partner planning conception
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04288999Phase 3RecruitingUpdate OverdueUpdated 72mo ago · Completion was 11mo agoJCOG1801: 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)
In Brief
A Phase 3 clinical trial evaluating Chemotherapy, Preoperative radiotherapy, and 1 other intervention for Rectal Cancer Recurrent. Currently recruiting, targeting 110 participants across 45 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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)
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