Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer (GECA)
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ClinicalTrials.gov Identifier: NCT01303029 |
Recruitment Status :
Completed
First Posted : February 24, 2011
Last Update Posted : August 1, 2017
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Sponsor:
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Tracking Information | |||||||
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First Submitted Date ICMJE | February 16, 2011 | ||||||
First Posted Date ICMJE | February 24, 2011 | ||||||
Last Update Posted Date | August 1, 2017 | ||||||
Study Start Date ICMJE | February 2011 | ||||||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Progression free survival [ Time Frame: 4 years ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer | ||||||
Official Title ICMJE | A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer | ||||||
Brief Summary | The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer. | ||||||
Detailed Description | Not Provided | ||||||
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 | Metastatic Pancreatic Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Irigoyen A, Gallego J, Guillen Ponce C, Vera R, Iranzo V, Ales I, Arevalo S, Pisa A, Martin M, Salud A, Falco E, Saenz A, Manzano Mozo JL, Pulido G, Martinez Galan J, Pazo-Cid R, Rivera F, Garcia Garcia T, Serra O, Fernandez Parra EM, Hurtado A, Gomez Reina MJ, Lopez Gomez LJ, Martinez Ortega E, Benavides M, Aranda E; Spanish Cooperative Group of Treatment of Digestive Tumors (TTD). Gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in the first-line treatment of patients with metastatic pancreatic cancer: Efficacy and safety results of a phase IIb randomised study from the Spanish TTD Collaborative Group. Eur J Cancer. 2017 Apr;75:73-82. doi: 10.1016/j.ejca.2016.12.032. Epub 2017 Mar 7. | ||||||
* 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 |
120 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | June 2015 | ||||||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | Spain | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01303029 | ||||||
Other Study ID Numbers ICMJE | TTD-10-01 2010-022599-30 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | ||||||
Original Responsible Party | Spanish Cooperative Group for Digestive Tumour Therapy | ||||||
Current Study Sponsor ICMJE | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Hoffmann-La Roche | ||||||
Investigators ICMJE |
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PRS Account | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | ||||||
Verification Date | July 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |