Back to resultsGenotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Irinotecan
Capecitabine
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Neoadjuvant chemotherapy, rectal cancer, phase I study, irinotecan
Eligibility Criteria
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
Sites / Locations
- Cancer Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Irinotecan
Arm Description
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Outcomes
Primary Outcome Measures
toxicity
Grade 4 hemato-toxicity
Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
Secondary Outcome Measures
pathological complete response (pCR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01474187
Brief Title
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
Official Title
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Neoadjuvant chemotherapy, rectal cancer, phase I study, irinotecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irinotecan
Arm Type
Experimental
Arm Description
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
initial from 50mg/m2/week and increased by 15mg/m2/week
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
625mg/m2,bid,d1-5,qw
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
50Gy for whole pelvis
Primary Outcome Measure Information:
Title
toxicity
Description
Grade 4 hemato-toxicity
Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
pathological complete response (pCR)
Time Frame
within 14days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Zhu, MD
Email
leo.zhu@126.com
Facility Information:
Facility Name
Cancer Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Zhu, MD
Email
leo.zhu@126.com
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, MD
First Name & Middle Initial & Last Name & Degree
Ji Zhu, MD
12. IPD Sharing Statement
Learn more about this trial
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
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