drugset / Trial / NCT05375708
Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer Up to 10 Metastatic Sites
RandomizedParallel-groupOpen-labelTreatment
Summary
A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis. The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.
Timeline
- Start
- 2025-12-01
- Primary completion
- 2031-06-01
- Completion
- 2034-06-01
Outcome
Outcome not reported
Stopped: “Pilot study findings pointed to a overhaul in study design”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Maintenance therapy (CAP-B or 5-FU/LV plus bevacizumab.) | Unknown | 30 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 3200 mg/m2 | Intravenous |