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Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

NCT ID: NCT00320320

Last Updated: 2008-11-25

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-04-30

Brief Summary

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The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Detailed Description

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For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Conditions

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Colorectal Neoplasms Metastases

Keywords

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No prior chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Irinotecan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically proven adenocarcinoma of colon and rectum
* No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy
* Advanced, metastatic or recurrent not amenable to curative local therapy
* Measurable lesion(s)
* ECOG performance status 0 to 2
* Normal marrow, hepatic and renal function
* Provision of written informed consent

Exclusion Criteria

* Active infection and/or severe comorbidity
* Known history of anaphylaxis of any origin
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Se Hoon Park, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center, Incheon, Korea

Locations

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Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GMO-GI-53

Identifier Type: -

Identifier Source: org_study_id