Trial record 20 of 3324 for:
Louisville
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin (DELTIC)
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ClinicalTrials.gov Identifier: NCT01648023 |
Recruitment Status
:
Recruiting
First Posted
: July 24, 2012
Last Update Posted
: February 14, 2018
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Sponsor:
Robert C. Martin
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 17, 2012 | ||||||||
First Posted Date ICMJE | July 24, 2012 | ||||||||
Last Update Posted Date | February 14, 2018 | ||||||||
Study Start Date ICMJE | July 2012 | ||||||||
Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Tumor response according to modified RECIST Criteria [ Time Frame: 10 Weeks ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01648023 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Hepatic Progression Free Survival [ Time Frame: Progression ] | ||||||||
Original Secondary Outcome Measures ICMJE |
Hepatic Progression Free Survival | ||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin | ||||||||
Official Title ICMJE | Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma | ||||||||
Brief Summary | The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Unresectable Intrahepatic Cholangiocarcinoma | ||||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||||
* 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE |
48 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date | July 2020 | ||||||||
Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01648023 | ||||||||
Other Study ID Numbers ICMJE | 11-0181 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Robert C. Martin, University of Louisville | ||||||||
Study Sponsor ICMJE | Robert C. Martin | ||||||||
Collaborators ICMJE | University of Louisville | ||||||||
Investigators ICMJE |
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PRS Account | University of Louisville | ||||||||
Verification Date | December 2017 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |