Platine, Avastin and OLAparib in 1st Line
PAOLA-1
Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment
1 other identifier
interventional
806
11 countries
163
Brief Summary
Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started May 2015
Typical duration for phase_3 ovarian-cancer
163 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
Study Start
First participant enrolled
May 6, 2015
CompletedFirst Submitted
Initial submission to the registry
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2022
CompletedAugust 2, 2022
August 1, 2022
3.9 years
June 18, 2015
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy by progression free survival (PFS1)
phase up to a total of 15 months
Secondary Outcomes (7)
Overall survival
Study end
Time to earliest progression by RECIST or CA-125
Study end
Second Progression Free Survival (PFS2)
Study end
Time to start of first subsequent therapy or death (TFST)
Study end
Time to start of second subsequent therapy or death (TSST)
Study end
- +2 more secondary outcomes
Study Arms (2)
Olaparib
EXPERIMENTALTablets per os 300 mg
Placebo
PLACEBO COMPARATORTablets per os 300 mg
Interventions
Eligibility Criteria
You may qualify if:
- I-1. Female Patient must be ≥18 years of age. I-2. Signed informed consent and ability to comply with treatment and follow-up.
- I-3. Patient with newly diagnosed I-3-1 Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer,
- I-3-2 Histologically confirmed (based on local histopathological findings):
- high grade serous or
- high grade endometrioid or
- other epithelial non mucinous ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation I-3-3 at an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification.
- I-4. Patient who has completed prior to randomization first line platinum-taxane chemotherapy:
- Platinum-taxane based regimen must have consisted of a minimum of 6 treatment cycles and a maximum of 9. However if platinum based therapy must be discontinued early as a result of non hematological toxicity specifically related to the platinum regimen, (i.e. neurotoxicity, hypersensitivity etc.), patient must have received a minimum of 4 cycles of the platinum regimen.
- Intravenous, intraperitoneal, or neoadjuvant platinum based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle. Interval debulking is allowed.
- I-5. Patient must have received prior to randomization a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of platinum-based chemotherapy. Only in case of interval debulking surgery, it is allowed to realize only 2 cycles of bevacizumab in combination with the last 3 cycles of platinium-based chemotherapy. Bevacizumab treatment should be administered at a dose 15mg/kg q3 weeks up to a total of 15 months.
- I-6. Patient must be prior to randomization without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment. There should be no clinical evidence of disease progression (physical exam, imagery, CA 125) throughout her first line treatment and prior to study randomization.
- I-7. Patient must be randomized at least 3 weeks and no more than 9 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTC AE grade 1 or better (except alopecia and peripheral neuropathy).
- I-8. Patient must have normal organ and bone marrow function:
- Hemoglobin ≥ 10.0 g/dL.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- +10 more criteria
You may not qualify if:
- E-1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
- E-2. Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
- E-3. Patient with synchronous primary endometrial cancer unless both of the following criteria are met:
- stage \< II,
- Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1 or 2 endometrioid adenocarcinoma.
- Patient with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.
- E-4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may be eligible provided she completed her adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease.
- Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment.
- E-5. Patient with myelodysplastic syndrome/acute myeloid leukemia history E-6. Patient having experienced for at least one cycle, a delay \> 2 weeks due to prolonged hematological recovery during the first line chemotherapy E-7. Patient receiving radiotherapy within 6 weeks prior to study treatment E-8. Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery E-9. Previous allergenic bone marrow transplant. E-10. Any previous treatment with PARP inhibitor, including olaparib. E-11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
- E-12. Current or recent (within 10 days prior to randomization) chronic use of aspirin \> 325 mg/day.
- E-13. Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
- E-14. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
- E-15. Clinically significant (e.g. active) cardiovascular disease, including:
- Myocardial infarction or unstable angina within ≤ 6 months of randomization,
- New York Heart Association (NYHA) ≥ grade 2congestive heart failure (CHF).
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arcagy Researchlead
- Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germanycollaborator
- Arbeitsgemeinschaft Gynaekologische Onkologie Austriacollaborator
- Grupo Español de Investigación en Cáncer de Ovariocollaborator
- Belgian Gynaecological Oncology Groupcollaborator
- Multicenter Italian Trials in Ovarian cancer and gynecologic malignanciescollaborator
- Mario Negri Gynecologic Oncology group (MaNGO)collaborator
- Nordic Society of Gynaecological Oncology - Clinical Trials Unitcollaborator
- Gynecologic Oncology Trial & Investigation Consortiumcollaborator
Study Sites (163)
KH der Barmherzigen Brüder Graz
Graz, 8020, Austria
Medical University of Graz
Graz, 8036, Austria
Medical University of Innsbruck
Innsbruck, 6020, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Medical University of Vienna
Vienna, 1090, Austria
Krankenhaus Hietzing
Vienna, 1130, Austria
Institut Jules Bordet
Brussels, B1000, Belgium
Antwerp University Hospital
Edegem, B-2650, Belgium
UZ Gasthuisberg
Leuven, B - 3000, Belgium
Hôpital de la Citadelle
Liège, B-4000, Belgium
Clinique et maternité Sainte Elisabeth
Namur, B-5000, Belgium
CHU Dinant Godinne
Yvoir, B-5530, Belgium
Rigshospitalet
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2720, Denmark
Kuopio University Hospital
Kuopio, 70210, Finland
Oulu University Hospital
Oulu, FIN-90029, Finland
Tampere University Hospital
Tampere, FI-33521, Finland
Turku University Hospital
Turku, Finland
Hôpital Européen Georges Pompidou
Paris, Ilhe de France, 75015, France
ICO Paul Papin
Angers, 49100, France
Institut Sainte-Catherine
Avignon, 84918, France
Hôpital Jean Minjoz
Besançon, 25030, France
Institut Bergonié
Bordeaux, 33076, France
Polyclinique Bordeaux Nord
Bordeaux, 33300, France
Centre François Baclesse
Caen, 14000, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
Centre Georges François Leclerc
Dijon, 21079, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, 85925, France
Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700, France
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez
Lille, 59037, France
Centre Oscar Lambret
Lille, 59200, France
Centre Léon Bérard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
Hôpital de Mont-de-Marsan
Mont-de-Marsan, 40024, France
ICM Val d'Aurelle
Montpellier, 34298, France
Centre Azuréen de Cancérologie
Mougins, 06250, France
Centre Catherine de Sienne - Group confluent
Nantes, 44202, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre Hospitalier Régional d'Orléans
Orléans, 45067, France
Institut Curie - Hopital Claudius Régaud
Paris, 75005, France
Hôpital des Diaconesses
Paris, 75012, France
Hôpital Cochin
Paris, 75014, France
Hopital Tenon
Paris, 75020, France
Groupe Hospitalier Saint-Joseph
Paris, 75674, France
Clinique Francheville
Périgueux, 20004, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre CARIO - HPCA
Plérin, 22190, France
Hôpital de la Milétrie - CHU de Poitiers - Pôle Régional de Cancérologie
Poitiers, 86021, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
Hôpital René Huguenin, Institut Curie
Saint-Cloud, 92210, France
ICO Centre René Gauducheau
Saint-Herblain, 44805, France
Centre de Radiothérapie - Clinique Sainte-Anne
Strasbourg, 67000, France
Centre Paul Strauss
Strasbourg, 67065, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200, France
Institut Claudius Regaud
Toulouse, 31059, France
Clinique Pasteur - ONCOSUD
Toulouse, 31076, France
ICL Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum Aschaffenburg
Aschaffenburg, 63739, Germany
Klinikum Augsburg
Augsburg, 86156, Germany
Hochtaunus-Kliniken
Bad Homburg, 61352, Germany
Praxisklinik Krebsheilkunde für Frauen
Berlin, 10367, Germany
HELIOS Klinikum Berlin-Buch
Berlin, 13125, Germany
Charité - Universitätsmedizin Berlin (CVK)
Berlin, 13353, Germany
Onkologie Bottrop
Bottrop, 46236, Germany
GYNAEKOLOGICUM Bremen
Bremen, 28111, Germany
Universitätsfrauenklinik Köln
Cologne, 50931, Germany
St. Elisabeth Krankenhaus
Cologne, 50935, Germany
Städtisches Klinikum Dessau
Dessau, 06847, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Universitätsfrauenklinik Erlangen
Erlangen, 91054, Germany
Kliniken Essen Mitte
Essen, 45136, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, 60590, Germany
Klinikum Frankfurt Höchst
Frankfurt, 65929, Germany
Universitätsfrauenklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Universitäts-Frauenklinik Göttingen
Göttingen, 37075, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Klinkum Gütersloh
Gütersloh, 33332, Germany
Universitätsklinikum Halle
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Albertinen Krankenhaus
Hamburg, 22457, Germany
Gynäkologisch-Onkologische Praxis Hannover
Hanover, 30177, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Jena
Jena, 07743, Germany
St. Vincentius Kliniken
Karlsruhe, 76135, Germany
Klinikum Kassel
Kassel, 34125, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Klinikum Konstanz
Konstanz, 78462, Germany
HELIOS Klinikum Krefeld
Krefeld, 47805, Germany
Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Universitätsklinikum Gießen und Marburg
Marburg, 35043, Germany
Johannes Wesling Klinikum
Minden, 32429, Germany
Klinikum der Universität München
München, 81377, Germany
Klinikum rechts der Isar
München, 81675, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Kliniken des Landkreises Neumarkt
Neumarkt, 92318, Germany
Sana Klinikum Offenbach
Offenbach, 63069, Germany
Ortenau Klinikum
Offenburg, 77654, Germany
Onkologie Ravensburg
Ravensburg, 88212, Germany
Universitätsfrauenklinik Regensburg
Regensburg, 93053, Germany
Klinikum am Steinenberg
Reutlingen, 72764, Germany
ROMed Klinikum Rosenheim
Rosenheim, 83022, Germany
Klinikum Südstadt
Rostock, 18059, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Universitäts-Frauenklinik Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Ulm
Ulm, 89075, Germany
HELIOS Dr. Horst Schmidt Kliniken
Wiesbaden, 65199, Germany
Marien Hospital Witten
Witten, 58452, Germany
amO Wolfsburg
Wolfsburg, 38440, Germany
Klinikum Worms
Worms, 67550, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Centro Riferimento Oncologico
Aviano, 33081, Italy
Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Spedali Civili-Università di Brescia
Brescia, 25120, Italy
Ospedale Senatore Antonio Perrino
Brindisi, 72100, Italy
EO Ospedali Galliera
Genova, 16128, Italy
Ospedale San Luca
Lucca, 55100, Italy
Istituto Nazionale Tumori
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Istituto Nazionale Tumori - IRCCS Pascale
Napoli, 80131, Italy
Istituto Oncologico Veneto
Padua, 35128, Italy
Ospedale Santa Maria della Misericordia
Perugia, 06122, Italy
Ospedale Santa Chiara
Pisa, 56124, Italy
AO ASL 4 - Ospedale di Prato
Prato, 59100, Italy
Arcispedale S. M. Nuova
Reggio Emilia, 42100, Italy
Istituto Regina Elena
Roma, 00144, Italy
Policlinico Umberto I La Sapienza
Roma, 00161, Italy
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore
Roma, 00168, Italy
Ospedale S. Anna
Torino, 10126, Italy
Ospedale Mauriziano
Torino, 10128, Italy
Ospedale Santa Chiara
Trento, 38100, Italy
Ehime University Hospital
Ehime, 791-0204, Japan
Hyogo Cancer Center
Hyōgo, 673-0021, Japan
University of Tsukuba Hospital
Ibaraki, 305-0005, Japan
Kagoshima University Medical And Dental Hospital
Kagoshima, 890-8520, Japan
Saitama Medical University International Medical Center
Saitama, 350-1298, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Centre Hospitalier Princesse Grace
Monaco, 98000, Monaco
H. U. Fundación Alcorcón
Alcorcón, 28922, Spain
H. de la Santa Creu i Sant Pau
Barcelona, 8026, Spain
C.S. Parc Taulí
Barcelona, 8208, Spain
H. U. Reina Sofía
Córdoba, 14004, Spain
H.U. Arnau de Vilanova
Lleida, 25198, Spain
MD Anderson Cancer Center Madrid
Madrid, 28033, Spain
H. U. Ramón y Cajal
Madrid, 28034, Spain
H. U. 12 de Octubre
Madrid, 28041, Spain
H.U. Central de Asturias
Oviedo, 33011, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
H. General Universitario de Valencia
Valencia, 46014, Spain
H. U. P. La Fe
Valencia, 46026, Spain
H. U. Miguel Servet
Zaragoza, 50009, Spain
Linköping University Hospital
Linköping, 58185, Sweden
Related Publications (9)
Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.
PMID: 31851799RESULTBarnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.
PMID: 39695768DERIVEDMontegut C, Falandry C, Cinieri S, Cropet C, Montane L, Rousseau F, Joly F, Moubarak M, Mosconi AM, Guerra-Alia EM, Schauer C, Fujiwara H, Vergote I, Parma G, Lindahl G, Anota A, Canzler U, Marme F, Pujade-Lauraine E, Ray-Coquard I, Sabatier R. Safety and quality of life with maintenance olaparib plus bevacizumab in older patients with ovarian cancer: subgroup analysis of PAOLA-1/ENGOT-ov25. Oncologist. 2025 Jul 4;30(7):oyae322. doi: 10.1093/oncolo/oyae322.
PMID: 39673779DERIVEDHarter P, Marth C, Mouret-Reynier MA, Cropet C, Lorusso D, Guerra-Alia EM, Matsumoto T, Vergote I, Colombo N, Maenpaa J, Lebreton C, de Gregorio N, Mosconi AM, Rubio-Perez MJ, Bourgeois H, Fasching PA, Cecere SC, Hardy-Bessard AC, Denschlag D, de Percin S, Hanker L, Favier L, Bauerschlag D, Desauw C, Hillemanns P, Largillier R, Sehouli J, Grenier J, Pujade-Lauraine E, Ray-Coquard I; PAOLA-1/ENGOT-ov25 investigators. Efficacy of subsequent therapies in patients with advanced ovarian cancer who relapse after first-line olaparib maintenance: results of the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2025 Feb;36(2):185-196. doi: 10.1016/j.annonc.2024.10.828. Epub 2024 Nov 9.
PMID: 39528049DERIVEDLorusso D, Mouret-Reynier MA, Harter P, Cropet C, Caballero C, Wolfrum-Ristau P, Satoh T, Vergote I, Parma G, Nottrup TJ, Lebreton C, Fasching PA, Pisano C, Manso L, Bourgeois H, Runnebaum I, Zamagni C, Hardy-Bessard AC, Schnelzer A, Fabbro M, Schmalfeldt B, Berton D, Belau A, Lotz JP, Gropp-Meier M, Gladieff L, Luck HJ, Abadie-Lacourtoisie S, Pujade-Lauraine E, Ray-Coquard I. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial. Int J Gynecol Cancer. 2024 Apr 1;34(4):550-558. doi: 10.1136/ijgc-2023-004995.
PMID: 38129136DERIVEDCallens C, Rodrigues M, Briaux A, Frouin E, Eeckhoutte A, Pujade-Lauraine E, Renault V, Stoppa-Lyonnet D, Bieche I, Bataillon G, Karayan-Tapon L, Rochelle T, Heitz F, Cecere SC, Perez MJR, Grimm C, Nottrup TJ, Colombo N, Vergote I, Yonemori K, Ray-Coquard I, Stern MH, Popova T. Shallow whole genome sequencing approach to detect Homologous Recombination Deficiency in the PAOLA-1/ENGOT-OV25 phase-III trial. Oncogene. 2023 Nov;42(48):3556-3563. doi: 10.1038/s41388-023-02839-8. Epub 2023 Nov 9.
PMID: 37945748DERIVEDPujade-Lauraine E, Brown J, Barnicle A, Wessen J, Lao-Sirieix P, Criscione SW, du Bois A, Lorusso D, Romero I, Petru E, Yoshida H, Vergote I, Colombo N, Hietanen S, Provansal M, Schmalfeldt B, Pignata S, Martin Lorente C, Berton D, Runnebaum IB, Ray-Coquard I. Homologous Recombination Repair Gene Mutations to Predict Olaparib Plus Bevacizumab Efficacy in the First-Line Ovarian Cancer PAOLA-1/ENGOT-ov25 Trial. JCO Precis Oncol. 2023 Jan;7:e2200258. doi: 10.1200/PO.22.00258.
PMID: 36716415DERIVEDGonzalez-Martin A, Desauw C, Heitz F, Cropet C, Gargiulo P, Berger R, Ochi H, Vergote I, Colombo N, Mirza MR, Tazi Y, Canzler U, Zamagni C, Guerra-Alia EM, Levache CB, Marme F, Bazan F, de Gregorio N, Dohollou N, Fasching PA, Scambia G, Rubio-Perez MJ, Milenkova T, Costan C, Pautier P, Ray-Coquard I; PAOLA1/ENGOT-ov25 investigators. Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial. Eur J Cancer. 2022 Oct;174:221-231. doi: 10.1016/j.ejca.2022.07.022. Epub 2022 Sep 5.
PMID: 36067615DERIVEDFujiwara K, Fujiwara H, Yoshida H, Satoh T, Yonemori K, Nagao S, Matsumoto T, Kobayashi H, Bourgeois H, Harter P, Mosconi AM, Vazquez IP, Reinthaller A, Fujita T, Rowe P, Pujade-Lauraine E, Ray-Coquard I. Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial. J Gynecol Oncol. 2021 Sep;32(5):e82. doi: 10.3802/jgo.2021.32.e82.
PMID: 34378365DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle RAY COQUARD, MD, PhD
Centre Leon Berard
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 23, 2015
Study Start
May 6, 2015
Primary Completion
March 22, 2019
Study Completion
March 22, 2022
Last Updated
August 2, 2022
Record last verified: 2022-08