Sorafenib Tosylate With or Without Everolimus in Treating Patients With Localized, Unresectable, or Metastatic Liver Cancer
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ClinicalTrials.gov Identifier: NCT01005199 |
Recruitment Status :
Completed
First Posted : October 30, 2009
Last Update Posted : May 15, 2019
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | October 29, 2009 | ||||||||||||
First Posted Date ICMJE | October 30, 2009 | ||||||||||||
Last Update Posted Date | May 15, 2019 | ||||||||||||
Study Start Date ICMJE | November 2009 | ||||||||||||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: at 12 weeks ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
Progression-free survival at 12 weeks | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Sorafenib Tosylate With or Without Everolimus in Treating Patients With Localized, Unresectable, or Metastatic Liver Cancer | ||||||||||||
Official Title ICMJE | Sorafenib Alone or in Combination With Everolimus in Patients With Unresectable Hepatocellular Carcinoma. A Randomized Multicenter Phase II Trial. | ||||||||||||
Brief Summary | RATIONALE: Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This randomized phase II trial is studying giving sorafenib tosylate together with everolimus to see how well it works compared with sorafenib tosylate alone in treating patients with localized, unresectable, or metastatic liver cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to WHO performance status (0 vs 1), disease spread (extrahepatic spread vs non-extrahepatic spread), and center. Patients are randomized to 1 of 2 treatment arms.
Some patients may undergo CT scan or MRI at baseline and at 6 and 12 weeks during study to assess tumor response, tumor size, and tumor density. Patients complete quality of life questionnaires at baseline and every 2 weeks for 12 weeks during study treatment. After completion of study treatment, patients are followed every 2 months for 3 years. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Liver Cancer | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Koeberle D, Dufour JF, Demeter G, Li Q, Ribi K, Samaras P, Saletti P, Roth AD, Horber D, Buehlmann M, Wagner AD, Montemurro M, Lakatos G, Feilchenfeldt J, Peck-Radosavljevic M, Rauch D, Tschanz B, Bodoky G; Swiss Group for Clinical Cancer Research (SAKK). Sorafenib with or without everolimus in patients with advanced hepatocellular carcinoma (HCC): a randomized multicenter, multinational phase II trial (SAKK 77/08 and SASL 29). Ann Oncol. 2016 May;27(5):856-61. doi: 10.1093/annonc/mdw054. Epub 2016 Feb 15. | ||||||||||||
* 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 |
106 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Actual Study Completion Date ICMJE | March 2016 | ||||||||||||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | Austria, Hungary, Switzerland | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT01005199 | ||||||||||||
Other Study ID Numbers ICMJE | SAKK 77/08 and SASL 29 SWS-SAKK-77/08 ( Other Identifier: SAKK ) SWS-SASL-29 2009-011884-35 ( EudraCT Number ) EU-20983 CDR0000657702 |
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Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Swiss Group for Clinical Cancer Research | ||||||||||||
Original Responsible Party | Not Provided | ||||||||||||
Current Study Sponsor ICMJE | Swiss Group for Clinical Cancer Research | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | Swiss Group for Clinical Cancer Research | ||||||||||||
Verification Date | May 2019 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |