drugset / Trial / NCT01474187
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.
Timeline
- Start
- 2011-11
- Primary completion
- 2011-11
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 50 mg/m2 | — |
| Background | Capecitabine | Small molecule | 625 mg/m2 | — |