Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

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

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-11-30

Brief Summary

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This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

S-1 plus LV

Group Type EXPERIMENTAL

S-1 plus LV (The combination therapy of S-1 and Leucovorin)

Intervention Type DRUG

S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7

Interventions

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S-1 plus LV (The combination therapy of S-1 and Leucovorin)

S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically proved adenocarcinoma
* Unresectable and recurrent colorectal cancer
* Age20 ≤ at enrollment
* Performance status 0 or 1 (ECOG)
* No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
* Adequate hematologic, hepatic and renal functions
* At least one measurable lesion by RECIST criteria

Exclusion Criteria

* Serious drug hypersensitivity
* Pregnant or nursing
* Bleeding from gastrointestinal tract
* Diarrhea
* Simultaneously active double cancer
* Serious illness or medical condition
* Brain metastasis

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No