drugset / Trial / NCT03904043
Non-Operative Management and Early Response Assessment in Rectal Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2024-08-21
- Completion
- 2026-01-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | — | — |
| Background | Levoleucovorin | Unknown | — | — |