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

Taiho Pharma

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891332

Taiho10020400

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

1

Experimental group

Description:

S-1 plus LV

Treatment:

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