Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors (ABC-02)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00262769 |
Recruitment Status :
Completed
First Posted : December 7, 2005
Last Update Posted : July 17, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | December 6, 2005 | |||
First Posted Date ICMJE | December 7, 2005 | |||
Last Update Posted Date | July 17, 2012 | |||
Study Start Date ICMJE | May 2005 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ] From date of randomisation till date of death or last date of follow-up (up to 5 years)
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors | |||
Official Title ICMJE | Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors. PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary site of disease (gallbladder vs bile ducts vs ampulla), prior therapy (photodynamic therapy [PDT] vs non-PDT therapy vs none), ECOG performance status (0 vs 1 vs 2), and disease status (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, 12 weeks, and after finishing treatment. After completion of study treatment, patients are followed periodically for at least 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
324 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Chemotherapy
Radiotherapy
Surgery
Other
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00262769 | |||
Other Study ID Numbers ICMJE | CDR0000455013 CRUK-ABC-02 EU-205103 ISRCTN82956140 EUDRACT-2004-004882-14 CTA-21266/0005/001 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | University College, London | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | University College, London | |||
Original Study Sponsor ICMJE | Cancer Research UK | |||
Collaborators ICMJE | Eli Lilly and Company | |||
Investigators ICMJE |
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PRS Account | University College, London | |||
Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |