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Completed

NCT Number: NCT00721916

Randomized Phase II Study of SOL for 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shizuoka Cancer Center

Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: Until progression

Secondary outcomes

  1. Safety

    Time frame: During chemotherapy

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Yakult Honsha Co., LTD

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 25, 2008
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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