Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer
BOOST
A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
1 other identifier
interventional
927
6 countries
131
Brief Summary
The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2011
Longer than P75 for phase_3
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 20, 2022
July 1, 2022
9.2 years
October 25, 2011
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
every 12 weeks until progression or up to 30 months, thereafter every 6 months
Secondary Outcomes (6)
Objective response rate (ORR)
every 12 weeks until progression or up to 30 months, thereafter every 6 months
Overall survival (OS)
every 3 weeks, 31 months after start of treatment, thereafter every 6 months
Health related Quality of life (QoL)
baseline, then every 12 weeks until progression, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Safety and tolerability, i.e. type, frequency, severity and duration of adverse reactions
every 3 weeks, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Translational Research - Tumor Tissue Block
Assessment at end of study planned
- +1 more secondary outcomes
Study Arms (2)
Control Arm
OTHERPatients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab iv alone every 3 weeks for 16 cycles.
Research Arm
EXPERIMENTALPatients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab iv alone every 3 weeks for 38 cycles.
Interventions
15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44
Eligibility Criteria
You may qualify if:
- Signed written informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements
- Primary diagnosis is confirmed by specialized pathology review (Germany only)
- Females aged ≥ 18 years
- Histologically confirmed, newly diagnosed
- Epithelial ovarian carcinoma
- Fallopian tube carcinoma
- Primary peritoneal carcinoma AND FIGO stage IIb - IV (all grades and all histological types)
- Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in whom initial surgical debulking was not appropriate or possible will still be eligible providing
- the patient has a histological diagnosis and
- debulking surgery prior to disease progression is not foreseen
- Patients must be able to commence cytotoxic chemotherapy within 8 weeks of cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks of surgery.
- ECOG 0-2
- Life expectancy \> 3 months
- Adequate bone marrow function (within 14 days prior to randomization)
- ANC ≥ 1.5 x 10\^9/L
- +10 more criteria
You may not qualify if:
- Non-epithelial origin of the ovary, the fallopian tube or the peritoneum
- Borderline tumours (tumours of low malignant potential) and FIGO stage Ia - IIa tumours
- Planned intraperitoneal cytotoxic chemotherapy
- Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
- Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from the first cycle of chemotherapy). It is strongly recommended that an interval of 7 days is left between the insertion of any central venous access devices (CVADs) and the onset of bevacizumab treatment.
- Any planned surgery during the study treatment period plus 4 additional weeks to allow for bevacizumab clearance
- Uncontrolled hypertension (sustained elevation of BP systolic \> 150mmHg and/or diastolic \> 100mmHg despite antihypertensive therapy)
- Any previous radiotherapy to the abdomen or pelvis
- Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab
- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.
- History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures
- Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomization
- Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least 6 months afterwards
- Pregnant or lactating women
- Treatment with other investigational agents, or participation in another clinical trial testing a drug within the past 4 weeks before start of therapy concomitantly with this trial
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AGO Study Grouplead
- ARCAGY/ GINECO GROUPcollaborator
- Nordic Society of Gynaecological Oncology - Clinical Trials Unitcollaborator
Study Sites (131)
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Aalborg, Denmark
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Copenhagen, Denmark
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Herlev, Denmark
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Kuopio, Finland
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Oulu, Finland
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Tampere, Finland
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Turku, Finland
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Angers, France
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Besançon, France
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Blois, France
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Bordeaux, France
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Caen, France
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Cahors, France
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Clamart, France
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Clermont-Ferrand, France
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Créteil, France
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Dax, France
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Draguignan, France
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Grenoble, France
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Limoges, France
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Lyon, France
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Mougins, France
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Nancy, France
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Nantes, France
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Nice, France
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Nîmes, France
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Orléans, France
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Paris, France
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Pau, France
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Plérin, France
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Poitiers, France
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Quimper, France
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Reims, France
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Rouen, France
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Saint-Herblain, France
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Strasbourg, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Vannes, France
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Villejuif, France
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Aachen, Germany
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Arnsberg, Germany
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Aschaffenburg, Germany
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Augsburg, Germany
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Bad Homburg, Germany
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
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Bottrop, Germany
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Brandenburg, Germany
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Bremen, Germany
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Chemnitz, Germany
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Coburg, Germany
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Cologne, Germany
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Deggendorf, Germany
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Dessau, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Ebersberg, Germany
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Eggenfelden, Germany
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Erlangen, Germany
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Essen, Germany
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Esslingen am Neckar, Germany
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Flensburg, Germany
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Frankfurt/M., Germany
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Freiburg im Breisgau, Germany
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Fürstenfeldbruck, Germany
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Fürth, Germany
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Georgsmarienhütte, Germany
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Gera, Germany
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Göttingen, Germany
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Greifswald, Germany
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Gütersloh, Germany
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Halle, Germany
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Hamburg, Germany
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Hanau, Germany
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Hanover, Germany
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Heidelberg, Germany
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Henstedt-Ulzburg, Germany
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Hildesheim, Germany
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Jena, Germany
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Kaiserslautern, Germany
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Karlsruhe, Germany
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Kassel, Germany
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Kiel, Germany
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Krefeld, Germany
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Lich, Germany
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Limburg, Germany
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Lübeck, Germany
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Lüneburg, Germany
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Magdeburg, Germany
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Mainz, Germany
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Mannheim, Germany
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Marburg, Germany
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Minden, Germany
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München, Germany
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Neumarkt, Germany
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Neuss, Germany
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Nordhausen, Germany
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Offenbach, Germany
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Offenburg, Germany
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Oldenburg, Germany
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Osnabrück, Germany
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Ravensburg, Germany
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Regensburg, Germany
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Reutlingen, Germany
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Rosenheim, Germany
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Rostock, Germany
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Rottweil, Germany
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Saalfeld, Germany
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Salzgitter, Germany
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Schwäbisch Hall, Germany
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Schweinfurt, Germany
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Sigmaringen, Germany
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Solingen, Germany
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Stralsund, Germany
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Stuttgart, Germany
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Torgau, Germany
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Trier, Germany
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Tübingen, Germany
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Ulm, Germany
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Viersen, Germany
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Wiesbaden, Germany
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Witten, Germany
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Wolfsburg, Germany
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Worms, Germany
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Bergen, Norway
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Oslo, Norway
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Trondheim, Norway
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Falun, Sweden
Unknown Facility
Uppsala, Sweden
Related Publications (2)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVEDPfisterer J, Joly F, Kristensen G, Rau J, Mahner S, Pautier P, El-Balat A, Kurtz JE, Canzler U, Sehouli J, Heubner ML, Hartkopf AD, Baumann K, Hasenburg A, Hanker LC, Belau A, Schmalfeldt B, Denschlag D, Park-Simon TW, Selle F, Jackisch C, Burges A, Luck HJ, Emons G, Meier W, Gropp-Meier M, Schroder W, de Gregorio N, Hilpert F, Harter P. Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial. J Clin Oncol. 2023 Feb 1;41(4):893-902. doi: 10.1200/JCO.22.01010. Epub 2022 Nov 4.
PMID: 36332161DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jacobus Pfisterer, MD PhD
AGO Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2011
First Posted
November 1, 2011
Study Start
November 1, 2011
Primary Completion
December 31, 2020
Study Completion
December 1, 2021
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share