Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Taiho Pharma

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin); Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721916

Taiho10020390

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Active Comparator group

Description:

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

Treatment:

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