- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074996
Study of S-1 as Second Line Treatment on Advanced Pancreatic Cancers (APC-S1)
January 15, 2014 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
A Randomized , Open-label, Multicenter, Phase II Study to Compare the Efficacy of S-1 and S-1 Plus Leucovorin as Second Line Treatment on Gemcitabine-refractory Patients With Inoperable or Advanced Pancreatic Cancers
A randomized , open-label, multicenter, phase II study to compare the efficacy of S-1 and S-1 plus Leucovorin as second line treatment on gemcitabine-refractory patients with inoperable or advanced pancreatic cancers,investigate the correlation between efficacy and the expressions of thymidylate synthase, dihydropyrimidine dehydrogenase and orotate phosphoribosyltransferase
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100071
- 307 Hospital of PLA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed inoperable or APC.
- Failure of one prior gemcitabine-based regimen was required,chemotherapy used as a radiation sensitizer in the adjuvant or locally advanced setting was not considered as a prior regimen. Patients received last adjuvant gemcitabine-based chemotherapy less than (or equal to) six months can be enrolled into this study.
- Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Age ≥18 years old.
- ECOG performance status 0 or 1.
- Written informed consent and able to comply with the protocol.
Exclusion Criteria:
- Local (Stage IA to IIB) pancreatic cancer and locally advanced (stage III) pancreatic cancer. Patients relapsing with metastatic disease, after initial diagnoses with local disease can be enrolled into this study.
- Previous adjuvant radiotherapy for pancreatic cancer, except for patients with progressive lesions outside the radiation port who completed the radiotherapy at least 6 months prior to study entry.
- More than (or equal to) six months since last adjuvant chemotherapy. Adjuvant therapy without gemcitabine based adjuvant therapy is not allowed. Patient must have recovered from all treatment related toxicity prior to enrollment and must have documented evidence of disease progression (metastatic) following prior chemotherapy.
- No previous gemcitabine-based therapy for inoperable or APC.
- Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
- Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
- History or evidence upon neurological exam of CNS disease (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures.
- Inability to take oral medication, prior surgical procedures affecting absorption or resulting in the requirement for intravenous alimentation or parenteral nutrition with lipids, and/or active peptic ulcer disease
- Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start
- Men and women of childbearing potential (<2 years after last menstruation) not using effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study
- Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
- Known hypersensitivity to any of the study drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: S-1,
Subjects will receive S-1 until progression
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40-60mg bid , days 1-14, every 3 weeks
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Experimental: S-1 plus Leucovorin
patients will receive S-1 plus Leucovorin until progression
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S-1 40-60mg bid, days 1-14 , every 3 weeks Leucovorin 25mg bid , days 1-14 , every 3 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival(PFS)
Time Frame: up to 3 years
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Assuming a 1.8 months median PFS in the S-1 arm, the study was designed to detect an improvement in PFS to 3.5 months in the S-1 plus Leucovorin arm, or 96% prolongation.
The calculated number of PFS events needed to detect this difference with α (two-side) of 0.05 and power of 0.8 was 70.
Assuming an average enrollment rate of 2.2 patients per month during planned 3-years study period, a total of eighty patients would be able to provide sufficient number of PFS events for the study at end of the study.
However, a total of 90 patients were planned for the study, in consideration of comparison for safety and the overall survival between the two treatment groups.
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up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: up to 3 years
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up to 3 years
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Tumor response rate
Time Frame: up to 3 years
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up to 3 years
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Clinical benefit rate
Time Frame: up to 3 years
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up to 3 years
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safety and tolerance
Time Frame: up to 3 years
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up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xu Jianming, M.D., The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
October 1, 2013
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
February 23, 2010
First Submitted That Met QC Criteria
February 23, 2010
First Posted (Estimate)
February 24, 2010
Study Record Updates
Last Update Posted (Estimate)
January 16, 2014
Last Update Submitted That Met QC Criteria
January 15, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APC-307PLAH-XJM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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