drugset / Trial / NCT04288999

Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer

NCT04288999 ↗

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

Drugs

EvaluationDrugModalityDoseRoute
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 —

Indications