drugset / Trial / NCT01923987

Summary

Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30\~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.

Timeline

Start
2012-08
Primary completion
2020-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 600 mg/m2 Intravenous