Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

NCT ID: NCT00832689

Last Updated: 2011-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-03-31

Brief Summary

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The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.

Detailed Description

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Conditions

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Biliary Tract Cancer

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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1

Group Type EXPERIMENTAL

Irinotecan and Gemcitabine

Intervention Type DRUG

Interventions

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Irinotecan and Gemcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed inoperable biliary tract cancer
* Age: 18 \~75 years old
* Performance status: ECOG 0-2
* Hematopoietic:

* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hepatic:

* Bilirubin No greater than 2 fold the upper normal limit
* AST/ALT : No greater than 3 fold the upper normal limit
* Renal:

* Creatinine - no greater than 1.5 mg/dL
* Not pregnant
* No other serious medical or psychiatric illness that would preclude giving informed consent or limit
* No prior chemotherapy within 6 months
* No other concurrent anticancer radiotherapy within 6 months
Minimum Eligible Age

17 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Severance hospital

Principal Investigators

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Jeong Youp Park, MD

Role: STUDY_DIRECTOR

Assistant professor of division of Gastroenterology

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2007-0191

Identifier Type: -

Identifier Source: org_study_id

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