drugset / Trial / NCT05673772

Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

NCT05673772

RandomizedParallel-groupOpen-labelTreatment

Summary

The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.

Timeline

Start
2020-10-23
Primary completion
2028-12-28
Completion
2031-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Leucosodium Unknown 400 mg/m2
Subject Leucovroin Unknown 400 mg/m2
Subject Levoleucovorin Unknown 200 mg/m2
Subject Oxaliplatin Small molecule 85 mg/m2
Subject fluorouracil Small molecule 2400 mg/m2

Indications