Rectal Cancer
Conditions
Keywords
Neoadjuvant chemotherapy, rectal cancer, phase I study, irinotecan
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.
Interventions
DRUGIrinotecan
initial from 50mg/m2/week and increased by 15mg/m2/week
DRUGCapecitabine
625mg/m2,bid,d1-5,qw
RADIATIONRadiotherapy
50Gy for whole pelvis
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| toxicity | 5 weeks | * Grade 4 hemato-toxicity * Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity) |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR) | within 14days after surgery |
Countries
China
Contacts
Primary ContactJi Zhu, MD
Outcome results
None listed