drugset / Trial / NCT01952951
Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.
Timeline
- Start
- 2014-06
- Primary completion
- 2017-09
- Completion
- 2019-12
Outcome
Missed primary endpoint
paper In arms A and B, downstaging was achieved in 21.2% and 36.4% (P = .077), respectively PMID 29976501 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 850 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | — |