Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
NCT ID: NCT00721916
Last Updated: 2012-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2008-07-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
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
2
mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
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)
Interventions
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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
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior history of peripheral neuropathy.
* Diarrhea .
* Simultaneously active double cancer.
20 Years
ALL
No
Sponsors
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Yakult Honsha Co., LTD
INDUSTRY
Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Narikazu Boku, MD
Role: STUDY_CHAIR
St. Marianna University School of Medicine
Locations
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Shizuoka Cancer Center
Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan
Countries
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Other Identifiers
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Taiho10020390
Identifier Type: -
Identifier Source: org_study_id