Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

Phase 1

• Conditions: Rectal Cancer
• Interventions: Drug: Irinotecan; Drug: Capecitabine; Radiation: Radiotherapy

• Registration Number: NCT01474187
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Primary Completion: 2011-11
• Study First Submitted: 2011-11-11
• Study First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-15
• Study First Posted: 2011-11-18
• Last Update Posted: 2011-11-18
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan	Radiotherapy	irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Irinotecan	Capecitabine	irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Irinotecan	Irinotecan	irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week

Primary Outcome Measures

Name	Time	Method
toxicity	5 weeks	* Grade 4 hemato-toxicity; * Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)

Secondary Outcome Measures

Name	Time	Method
pathological complete response (pCR)	within 14days after surgery

Trial Locations

Locations (1)

Cancer Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China