drugset / Trial / NCT04288999
Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
Phase 3
Recruiting
110 enrolled
National Cancer Center Hospital East
Japan Agency for Medical Research and Development · collabJapan Clinical Oncology Group · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-10-01
- Primary completion
- 2025-08
- Completion
- 2028-10
Publications
- Hashimoto T, Tsukada Y, Ito M, Kanato K, Mizusawa J, Fukuda H, Tsukamoto S, Takashima A, Kanemitsu Y. Utility of circulating tumour DNA for prognosis and prediction of therapeutic effect in locally recurrent rectal cancer: study protocol for a multi-institutional, prospective observational study (JCOG1801A1, CAP-LR study). BMJ Open. 2023 Aug 16;13(8):e073217. doi: 10.1136/bmjopen-2023-073217.
- Kadota T, Tsukada Y, Ito M, Katayama H, Mizusawa J, Nakamura N, Ito Y, Bando H, Ando M, Onaya H, Fukuda H, Kanemitsu Y. 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: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study). Jpn J Clin Oncol. 2020 Aug 4;50(8):953-957. doi: 10.1093/jjco/hyaa058.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1650 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Background | Chemotherapy | Unknown | 200 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |