Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
Phase 1
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Rectal Cancer
Both
Rectal Cancer
Trial Information
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
toxicity
Outcome Description:
Grade 4 hemato-toxicity Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
Outcome Time Frame:
5 weeks
Safety Issue:
Yes
Authority:
China: Ethics Committee
Study ID:
FDRT-003
NCT ID:
NCT01474187
Start Date:
November 2011
Completion Date:
December 2012
Related Keywords:
- Rectal Cancer
- Neoadjuvant chemotherapy
- rectal cancer
- phase I study
- irinotecan
- Rectal Neoplasms
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