Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT01837251 |
Recruitment Status :
Completed
First Posted : April 23, 2013
Last Update Posted : July 13, 2021
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Sponsor:
AGO Research GmbH
Collaborators:
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
ARCAGY/ GINECO GROUP
Australia New Zealand Gynaecological Oncology Group
Scottish Gynaecological Cancer Study Group
Information provided by (Responsible Party):
AGO Research GmbH
Tracking Information | ||||
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First Submitted Date ICMJE | April 16, 2013 | |||
First Posted Date ICMJE | April 23, 2013 | |||
Last Update Posted Date | July 13, 2021 | |||
Actual Study Start Date ICMJE | May 2013 | |||
Actual Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
investigator-determined progression-free survival [ Time Frame: every 12 weeks until progression or up to 30 months (whichever occurs first) ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
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 | Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer | |||
Official Title ICMJE | A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer | |||
Brief Summary | Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin. | |||
Detailed Description | Not Provided | |||
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 | Recurrent Platinum-sensitive Ovarian Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, Sehouli J, Canzler U, Schmalfeldt B, Dean AP, Hein A, Zeimet AG, Hanker LC, Petit T, Marme F, El-Balat A, Glasspool R, de Gregorio N, Mahner S, Meniawy TM, Park-Simon TW, Mouret-Reynier MA, Costan C, Meier W, Reinthaller A, Goh JC, L'Haridon T, Baron Hay S, Kommoss S, du Bois A, Kurtz JE; AGO-OVAR 2.21/ENGOT-ov 18 Investigators. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 May;21(5):699-709. doi: 10.1016/S1470-2045(20)30142-X. Epub 2020 Apr 16. Erratum In: Lancet Oncol. 2022 Jun;23(6):e248. | |||
* 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 |
682 | |||
Original Estimated Enrollment ICMJE |
654 | |||
Actual Study Completion Date ICMJE | January 2021 | |||
Actual Primary Completion Date | January 2021 (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 | Australia, Austria, Belgium, France, Germany, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01837251 | |||
Other Study ID Numbers ICMJE | AGO-OVAR 2.21 / ENGOT ov-18 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | AGO Research GmbH | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | AGO Research GmbH | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | AGO Research GmbH | |||
Verification Date | July 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |