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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01474187
• Other study ID #: FDRT-003
• Status: Recruiting
• Phase: Phase 1
• First received: November 11, 2011
• Last updated: November 15, 2011
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Fudan University
• Contact: Ji Zhu, MD
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Irinotecan
initial from 50mg/m2/week and increased by 15mg/m2/week
• Capecitabine
625mg/m2,bid,d1-5,qw

Radiation:
• Radiotherapy
50Gy for whole pelvis

Locations

Country	Name	City	State
China	Cancer Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicity	Grade 4 hemato-toxicity; Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)	5 weeks	Yes
Secondary	pathological complete response (pCR)		within 14days after surgery	No