Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer
Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
1 other identifier
interventional
73
2 countries
6
Brief Summary
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started Oct 2008
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2009
CompletedFirst Posted
Study publicly available on registry
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJanuary 18, 2012
January 1, 2012
2.7 years
April 30, 2009
January 16, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
During chemotherapy
Secondary Outcomes (7)
Safety
During chemotherapy
Progression free survival (PFS)
Until progression
Disease control rate(DCR)
During chemotherapy
Time to treatment failure (TTF)
Until progression
Overall survival (OS)
Over two years from registration
- +2 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALS-1 plus LV
Interventions
S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
Eligibility Criteria
You may qualify if:
- Histologically proved adenocarcinoma
- Unresectable and recurrent colorectal cancer
- Age20 ≤ at enrollment
- Performance status 0 or 1 (ECOG)
- 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 containing treatment shall be excluded
- Adequate hematologic, hepatic and renal functions
- At least one measurable lesion by RECIST criteria
You may not qualify if:
- Serious drug hypersensitivity
- Pregnant or nursing
- Bleeding from gastrointestinal tract
- Diarrhea
- Simultaneously active double cancer
- Serious illness or medical condition
- Brain metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Sun Yat-sen University Cancer Center, Division of Oncology
Dong Feng Dong road,Guangzhou, Guangdong, 510060, China
Shanghai Fudan University Cancer Hospital, Division of Oncology
Dong An Road, Shanghai, 200032, China
PLA 307 Hospital, No.4 Division of Oncology
East Avenue, Fengtai District, Beijing, 100071, China
Beijing Cancer Hospital, Digestive System Medicine Department
Fucheng Road, Haidian District, Beijing, 100036, China
Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology
Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China
Graduate School of Medical Sciences Kumamoto University
1-1-1, Honjo Kumamoto-city, Kumamoto, 860-8556, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hideo Baba, M.D.
Graduate School of Medical Sciences Kumamoto University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2009
First Posted
May 1, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2011
Study Completion
November 1, 2011
Last Updated
January 18, 2012
Record last verified: 2012-01