- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01375972
Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma
December 5, 2011 updated by: JLee, Asan Medical Center
Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer
To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.
Study Overview
Status
Completed
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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-
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Seoul, Korea, Republic of, 138736
- Asan Medical Center
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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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathologically proven biliary adenocarinoma
- Age > 18
- Evaluable disease
- ECOG performance status of 2 or better
- No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
- Adequate bone marrow function A. WBCs > 4,000/µL, absolute neutrophil count [ANC]>1,500/µL B. Hemoglobin >9.0 g/dL C. Platelets > 100,000/µL
- Adequate kidney function (creatinine<1.5 mg/dL)
- Adequate liver function (bilirubin<1.5 mg/dL [< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction], transaminases levels<3 times the upper normal limit, and serum albumin of >2.5 mg/dL)
- No serious medical or psychological condition that would preclude study treatment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria:
- Other tumor type than adenocarcinoma
- Evidence of GI bleeding or GI obstruction
- Presence or history of CNS metastasis
- Pregnancy or breastfeeding
- Other serious illness or medical conditions
- Axial skeletal radiotherapy within 6 months
- Neuropathy grade 2 or worse
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SP treatment
S-1 plus cisplatin combination chemotherapy
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S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
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ACTIVE_COMPARATOR: GP treatment
Gemcitabine plus Cisplatin combination chemotherapy
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Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival rate at 6 months
Time Frame: 6 months
|
progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: 6 months
|
Response to chemotherapy will be assessed using RECIST 1.0 criteria.
|
6 months
|
Toxicities
Time Frame: Up to 24 months
|
Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0.
The types of toxicities and the proportions of patients who experience each toxicity will be described.
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Up to 24 months
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overall survival
Time Frame: up to 36 months
|
Overall survival is calculated from the date of enrollment to the date of death from any cause.
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up to 36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MJ Kang, MD, MSc, Asan Medical Center
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
March 1, 2008
Primary Completion (ACTUAL)
July 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
June 15, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (ESTIMATE)
June 20, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 6, 2011
Last Update Submitted That Met QC Criteria
December 5, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- AMC_0803
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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