drugset / Trial / NCT04009876
A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an exploratory, open-label, single arm, non-randomized, multicenter, phase II clinical trial to determine the efficacy and clinical complete response rate in patients with rectal cancer and tumor preoperative evaluation after NAC (Neoadjuvant Chemotherapy) with NALIRINOX (5-FU \[fluorouracil)/LV \[Leucovorin calcium\] + oxaliplatin + nal-IRI \[Liposomal Irinotecan\]) and chemoradiotherapy.
Timeline
- Start
- 2019-05-01
- Primary completion
- 2022-10-21
- Completion
- 2022-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan Sucrosofate | Other / unclassified | — | — |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |