Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer (ICOG)
Tracking Information | |||||
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First Received Date ICMJE | July 5, 2007 | ||||
Last Updated Date | July 30, 2008 | ||||
Start Date ICMJE | July 2007 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Disease-free survival [ Time Frame: 3-years ] | ||||
Original Primary Outcome Measures ICMJE |
Disease-free survival [ Time Frame: 3-year ] | ||||
Change History | Complete list of historical versions of study NCT00497107 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Overall survival, compliance, adverse events, QOL, tumor markers [ Time Frame: 3-years ] | ||||
Original Secondary Outcome Measures ICMJE |
Overall survival, Compliance, Adverse events, QOL, Tumor markers [ Time Frame: 3-year ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer | ||||
Official Title ICMJE | Phase III Randomized Controlled Clinical Study of UFT/LV Therapy Versus UFT/LV + PSK Therapy as Postoperative Adjuvant Therapy for Histological Stage IIIa and IIIb Colorectal Cancer | ||||
Brief Summary | The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival (DFS) as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance, adverse events, quality of life (QOL) and relationship with tumor factors. |
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Detailed Description | To conduct a randomized controlled trial comparing chemotherapy using UFT/LV and immunochemotherapy using UFT/LV combined with PSK in patients with histological stage IIIa and IIIb colorectal cancer (adenocarcinoma) who have undergone curative surgery without residual cancer (R0) using 3-year disease-free survival rate as primary endpoint, and also to analyze the 3-year overall survival, compliance, adverse events, QOL and relationship with tumor factors. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 300 | ||||
Estimated Completion Date | May 2013 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 20 Years to 79 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Japan | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00497107 | ||||
Other Study ID Numbers ICMJE | ICOG-CC01 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | |||||
Study Sponsor ICMJE | Iwate Medical University | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Iwate Medical University | ||||
Verification Date | July 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |