Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Fudan University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- toxicity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with rectal adenocarcinoma
- •Clinical staged T3/4 or any node-positive disease
- •Age of 18-75 years
- •Karnofsky Performance Status > 80
- •Adequate bone marrow reserve, renal and hepatic functions
- •Without previous antitumoural chemotherapy
- •No evidence of metastatic disease
- •Written informed consent before randomization
- •UGT1A1's genotype of 6/6 or 6/7
Exclusion Criteria
- •Clinical staged I or IV
- •Age of <18 or >75 years
- •Karnofsky Performance Status < 80
- •Previous pelvis radiotherapy
- •Previous antitumoural chemotherapy
- •Clinically significant internal disease
- •Refuse to write informed consent before randomization
- •UGT1A1's genotype of 7/7
Arms & Interventions
Irinotecan
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Intervention: Irinotecan (Drug)
Irinotecan
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Intervention: Capecitabine (Drug)
Irinotecan
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
toxicity
Time Frame: 5 weeks
* Grade 4 hemato-toxicity * Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
Secondary Outcomes
- pathological complete response (pCR)(within 14days after surgery)
Investigators
Zhu Ji
Chief of Department of Radiation Oncology, Cancer Hospital
Fudan University