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

Fudan University

Status and phase: Unknown; Phase 1

Conditions: Rectal Cancer

Treatments: Radiation: Radiotherapy; Drug: Capecitabine; Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT01474187

FDRT-003

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Irinotecan

Experimental group

Description:

irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week

Treatment:

Radiation: Radiotherapy

Drug: Capecitabine

Drug: Irinotecan