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Clinical Trial Record

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Study of S-1 as Second Line Treatment on Advanced Pancreatic Cancers

2010-02

2013-10

2014-07

92

Study Overview

Study of S-1 as Second Line Treatment on 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

N/A

  • Pancreatic Cancer
  • DRUG: S-1
  • DRUG: S-1 plus Leucovorin
  • APC-307PLAH-XJM

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 Registration Dates Results Reporting Dates Study Record Updates

2010-02-23  

N/A  

2014-01-15  

2010-02-23  

N/A  

2014-01-16  

2010-02-24  

N/A  

2014-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: S-1,

Subjects will receive S-1 until progression

EXPERIMENTAL: S-1 plus Leucovorin

patients will receive S-1 plus Leucovorin until progression

DRUG: S-1 plus Leucovorin

  • S-1 40-60mg bid, days 1-14 , every 3 weeks Leucovorin 25mg bid , days 1-14 , every 3 weeks
Primary Outcome MeasuresMeasure DescriptionTime Frame
Progression Free Survival(PFS)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.up to 3 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
overall survivalup to 3 years
Tumor response rateup to 3 years
Clinical benefit rateup to 3 years
safety and toleranceup to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Histologically confirmed inoperable or APC. 2. 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. 3. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 4. Age ≥18 years old. 5. ECOG performance status 0 or 1. 6. Written informed consent and able to comply with the protocol.
    Exclusion Criteria:
    1. 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. 2. 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. 3. 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. 4. No previous gemcitabine-based therapy for inoperable or APC. 5. 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. 6. Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases. 7. History or evidence upon neurological exam of CNS disease (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures. 8. 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 9. 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 10. 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) 11. Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study 12. 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 13. Known hypersensitivity to any of the study drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Xu jianming, M.D., The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Ge F, Xu N, Bai Y, Ba Y, Zhang Y, Li F, Xu H, Jia R, Wang Y, Lin L, Xu J. S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study. Oncologist. 2014 Nov;19(11):1133-4. doi: 10.1634/theoncologist.2014-0223. Epub 2014 Oct 1.
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