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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Zhu Ji, Fudan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474187
First Posted: November 18, 2011
Last Update Posted: November 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhu Ji, Fudan University
  Purpose
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.

Condition Intervention Phase
Rectal Cancer Drug: Irinotecan Drug: Capecitabine Radiation: Radiotherapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Zhu Ji, Fudan University:

Primary Outcome Measures:
  • toxicity [ Time Frame: 5 weeks ]
    • Grade 4 hemato-toxicity
    • Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)


Secondary Outcome Measures:
  • pathological complete response (pCR) [ Time Frame: within 14days after surgery ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Drug: Irinotecan
initial from 50mg/m2/week and increased by 15mg/m2/week
Drug: Capecitabine
625mg/m2,bid,d1-5,qw
Other Name: Xeloda
Radiation: Radiotherapy
50Gy for whole pelvis

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474187


Contacts
Contact: Ji Zhu, MD leo.zhu@126.com

Locations
China, Shanghai
Cancer Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ji Zhu, MD       leo.zhu@126.com   
Principal Investigator: Zhen Zhang, MD         
Sub-Investigator: Ji Zhu, MD         
Sponsors and Collaborators
Fudan University
  More Information

Responsible Party: Zhu Ji, Chief of Department of Radiation Oncology, Cancer Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01474187     History of Changes
Other Study ID Numbers: FDRT-003
First Submitted: November 11, 2011
First Posted: November 18, 2011
Last Update Posted: November 18, 2011
Last Verified: November 2011

Keywords provided by Zhu Ji, Fudan University:
Neoadjuvant chemotherapy
rectal cancer
phase I study
irinotecan

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors