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Completed

NCT Number: NCT01039506

An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)

The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Oncology, National Defense Medical College Hospital

Tokorozawa-shi, Saitama, 359-8513, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic colorectal cancer (adenocarcinoma)
  • UGT1A1 genotyped patients
  • Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)

Exclusion criteria

  • Contraindication of CPT-11
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
  • Patients to receiving CPT-11 as adjuvant chemotherapy
  • History of pelvic irradiation

Treatment and study plan

CPT-11 based regimens

Drug

Other names: FOLFIRI, CPT-11+S-1, CPT-11

Primary outcomes

  1. Progression free survival

    Time frame: Within 3 years

    Percentage of participants alive without disease progression

Secondary outcomes

  1. Overall survival

    Time frame: At 3 years

    Percentage of participants alive at end of study

  2. Time to treatment failure

    Time frame: Within 3 years

    Duration of time (in months) from treatment to failure

  3. Response rate

    Time frame: from Day 1 (treatment) through disease progression (within 3 years)

    Percentage of participants with an objective response

  4. Disease control rate

    Time frame: Within 3 years

    Percentage of participants with controlled disease

  5. Safety events

    Time frame: Within 3 years

    Adverse events will be collected during treatment

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Dec 25, 2009
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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