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


N/A
N/A
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

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


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

- ECOG PS 3-4

- Patients to receiving CPT-11 as adjuvant chemotherapy

- History of pelvic irradiation

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression free survival

Outcome Time Frame:

every two or three months

Safety Issue:

No

Principal Investigator

Wataru Ichikawa, MD. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, National Defense Medical College

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TOP009-061

NCT ID:

NCT01039506

Start Date:

October 2009

Completion Date:

March 2016

Related Keywords:

  • Metastatic Colorectal Cancer
  • UGT1A1, irinotecan
  • Colorectal Neoplasms

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