Addition of Enzalutamide to First Line Docetaxel for Castration Resistant Prostate Cancer (CHEIRON)
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ClinicalTrials.gov Identifier: NCT02453009 |
Recruitment Status : Unknown
Verified May 2015 by Orazio Caffo, Santa Chiara Hospital.
Recruitment status was: Recruiting
First Posted : May 25, 2015
Last Update Posted : May 25, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | May 19, 2015 | |||
First Posted Date ICMJE | May 25, 2015 | |||
Last Update Posted Date | May 25, 2015 | |||
Study Start Date ICMJE | October 2014 | |||
Estimated Primary Completion Date | September 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Rate of patients without progression (according to guideline of Prostate Cancer Clinical Trials Working Group 2 - PCWG2) [ Time Frame: 6 months after docetaxel first administration ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
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 | Addition of Enzalutamide to First Line Docetaxel for Castration Resistant Prostate Cancer | |||
Official Title ICMJE | CHemotherapy Plus Enzalutamide In First Line Therapy for Castration Resistant prOstate caNcer | |||
Brief Summary | The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to improve the disease control in first line CRPC patients. | |||
Detailed Description | CHEIRON trial is a phase II randomized study comparing docetaxel plus enzalutamide to docetaxel alone as first line for castration resistant prostate cancer. | |||
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 | Prostatic Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Caffo O, Ortega C, Nole F, Gasparro D, Mucciarini C, Aieta M, Zagonel V, Iacovelli R, De Giorgi U, Facchini G, Veccia A, Palesandro E, Verri E, Buti S, Razzini G, Bozza G, Maruzzo M, Ciccarese C, Schepisi G, Rossetti S, Maines F, Kinspergher S, Fratino L, Ermacora P, Nicodemo M, Giordano M, Sartori D, Scapoli D, Sabbatini R, Lo Re G, Morelli F, D'Angelo A, Vittimberga I, Lippe P, Carrozza F, Messina C, Galli L, Valcamonico F, Porta C, Pappagallo G, Aglietta M. Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial. Eur J Cancer. 2021 Sep;155:56-63. doi: 10.1016/j.ejca.2021.06.016. Epub 2021 Aug 3. | |||
* 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 | Unknown status | |||
Estimated Enrollment ICMJE |
232 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2016 | |||
Estimated Primary Completion Date | September 2016 (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 | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02453009 | |||
Other Study ID Numbers ICMJE | TN-CHEIRON | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Orazio Caffo, Santa Chiara Hospital | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Santa Chiara Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Santa Chiara Hospital | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |