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

Sponsor
Fudan University
Study ID
NCT01474187
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    initial from 50mg/m2/week and increased by 15mg/m2/week
  • Capecitabine — DRUG
    625mg/m2,bid,d1-5,qw
  • Radiotherapy — RADIATION
    50Gy for whole pelvis

Study Details

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.

Key Dates

Start date
Nov 30, 2011
Status verified
Nov 2011
Primary completion
Nov 30, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan
    irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week

Primary Outcome Measure

toxicity [ Time Frame: 5 weeks ]

Central Contacts

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