drugset / Trial / NCT06205485
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Phase 3
Recruiting
250 enrolled
Canadian Cancer Trials Group
Alliance for Clinical Trials in Oncology · collabECOG-ACRIN Cancer Research Group · collabNRG Oncology · collabSWOG Cancer Research Network · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
Timeline
- Start
- 2024-06-26
- Primary completion
- 2030-01-30
- Completion
- 2030-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Fluoruracil | Unknown | 400 mg | — |
| Comparator | Fluoruracil | Unknown | 2400 mg/m2 | — |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | — |