Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Phase 2CompletedNCT00721916

Taiho Pharmaceutical Co., Ltd.107 enrolled

Overview

This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Colorectal Cancer

Interventions

SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)DRUG

L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7

mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)DRUG

L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr～48hr)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proved adenocarcinoma (colorectal cancer). * Age: 20 ≤ at enrollment. * 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 or Oxaliplatin containing treatment shall be excluded. * At least one measurable lesion by RECIST criteria Exclusion Criteria: * Serious drug hypersensitivity. * Prior history of peripheral neuropathy. * Diarrhea . * Simultaneously active double cancer.

Locations (1)

Shizuoka Cancer Center

Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan

Outcomes

Primary Outcomes

Progression free survival (PFS)

Time frame: Until progression

Secondary Outcomes

Safety

Time frame: During chemotherapy

Data from ClinicalTrials.gov

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