Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin); Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Shizuoka
    • Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)	Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin); 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
Active Comparator: 2; mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)	Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS)	Until progression

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	During chemotherapy

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Collaborators: Yakult Honsha Co., LTD
• Investigators: Study Chair: Narikazu Boku, MD, St. Marianna University School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (Estimate): July 25, 2008

Study Record Updates

• Last Update Posted (Estimate): November 1, 2012
• Last Update Submitted That Met QC Criteria: October 31, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Oxaliplatin; Leucovorin
• Other Study ID Numbers: Taiho10020390