drugset / Trial / NCT03975049
Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Preoperative radiation with single agent chemotherapy as sensitizer is the standard care of locally advanced rectal cancer. Local irradiation significantly increases surgical complications and impairs quality of life. Combination chemotherapy alone seems promising and provides similar benefit to chemoradiation as neoadjuvant therapy. Early administration of systemic therapy is also proved beneficial for long-term survival. The purpose of this study is to compare the efficacy of chemotherapy alone with short-term modified FOLFOXIRI or long-term mFOLFOX with standard chemoradiation as neoadjuvant therapy for locally advanced rectal cancer.
Timeline
- Start
- 2019-08
- Primary completion
- 2024-07
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |