Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
1 other identifier
interventional
704
15 countries
65
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedAugust 5, 2015
August 1, 2013
10.3 years
November 1, 1999
August 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
Secondary Outcomes (3)
Progression-free survival as measured by Kaplan Meier and RECIST every 3 months for 2 years, every 6 months for 3 years, and then annually
Health-related quality of life as measured by Quality of Life Questionnaire-C30 after courses 1, 3 and 6, then at 6 and 12 months
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 within 4 weeks of surgery
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (65)
Hospital de Clinicas "Jose De San Martin"
Buenos Aires, 1120, Argentina
Shaare Zedek Medical Center
Buenos Aires, 1120, Argentina
Karl-Franzens-University Graz
Graz, A-8010, Austria
Innsbruck Universitaetsklinik
Innsbruck, A-6020, Austria
Allgemeines Krankenhaus - Universitatskliniken
Vienna, A-1090, Austria
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna, A-1100, Austria
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, 1090, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, B-2650, Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, B-8500, Belgium
U.Z. Gasthuisberg
Leuven, B-3000, Belgium
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2, Canada
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H4L 2M1, Canada
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, DK-2730, Denmark
Institut Bergonie
Bordeaux, 33076, France
Centre Oscar Lambret
Lille, 59020, France
Centre Hospitalier Regional et Universitaire de Lille
Lille, 59037, France
Institut Claudius Regaud
Toulouse, 31052, France
Martin Luther Universitaet
Halle, D-06112, Germany
Coombe Women's Hospital
Dublin, 8, Ireland
St. James's Hospital
Dublin, 8, Ireland
Spedali Civili di Brescia
Brescia, 25124, Italy
Mirano General Hospital
Mirano-Venice, 30035, Italy
Libero Istituto Universitario Campus Bio-Medico
Rome, 00155, Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano
Torino, 10128, Italy
Clinica Universitaria
Turin, 10138, Italy
Vrije Universiteit Medisch Centrum
Amsterdam, 1007 MB, Netherlands
Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 HA, Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ, Netherlands
Leiden University Medical Center
Leiden, 2300 CA, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, NL-6500 HB, Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE, Netherlands
Erasmus MC - Sophia Children's Hospital
Rotterdam, 3015 GJ, Netherlands
Haukeland Hospital - University of Bergen
Bergen, N-5021, Norway
Norwegian Radium Hospital
Oslo, N-0310, Norway
Hospitais da Universidade de Coimbra (HUC)
Coimbra, 3049, Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
Lisbon, 1099-023 Codex, Portugal
Institut d'Oncologia Corachan
Barcelona, 08.017, Spain
Hospital Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Central de Asturias
Oviedo, 33006, Spain
Lund University Hospital
Lund, SE-22185, Sweden
Karolinska University Hospital - Huddinge
Stockholm, S - 141 86, Sweden
Umea Universitet
Umeå, SE-901 87, Sweden
Uppsala University Hospital
Uppsala, SE-75185, Sweden
Royal United Hospital
Bath, England, BA1 3NG, United Kingdom
Cheltenham General Hospital
Cheltenham, England, GL53 7AN, United Kingdom
University College of London Hospitals
London, England, WIT 3AA, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, CH63 4JY, United Kingdom
James Cook University Hospital
Middlesbrough, England, TS4 3BW, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB, United Kingdom
Staffordshire General Hospital
Stafford, England, ST16 3SA, United Kingdom
Western Infirmary
Glasgow, Scotland, G11 6NT, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, CT9 4AN, United Kingdom
Related Publications (7)
Chi DS, Musa F, Dao F, Zivanovic O, Sonoda Y, Leitao MM, Levine DA, Gardner GJ, Abu-Rustum NR, Barakat RR. An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT). Gynecol Oncol. 2012 Jan;124(1):10-4. doi: 10.1016/j.ygyno.2011.08.014. Epub 2011 Sep 13.
PMID: 21917306BACKGROUNDVerleye L, Ottevanger PB, Kristensen GB, Ehlen T, Johnson N, van der Burg ME, Reed NS, Verheijen RH, Gaarenstroom KN, Mosgaard B, Seoane JM, van der Velden J, Lotocki R, van der Graaf W, Penninckx B, Coens C, Stuart G, Vergote I. Quality of pathology reports for advanced ovarian cancer: are we missing essential information? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial. Eur J Cancer. 2011 Jan;47(1):57-64. doi: 10.1016/j.ejca.2010.08.008. Epub 2010 Sep 16.
PMID: 20850296RESULTVergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.
PMID: 20818904RESULTFruehauf JP, Yu I, Parker R: In vitro drug response and biomarker profiles for ovarian cancer specimens obtained at initial debulking or after neoadjuvant chemotherapy (EORTC 55971). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2177, 2002.
RESULTTajik P, van de Vrie R, Zafarmand MH, Coens C, Buist MR, Vergote I, Bossuyt PMM, Kenter GG. The FIGO Stage IVA Versus IVB of Ovarian Cancer: Prognostic Value and Predictive Value for Neoadjuvant Chemotherapy. Int J Gynecol Cancer. 2018 Mar;28(3):453-458. doi: 10.1097/IGC.0000000000001186.
PMID: 29324537DERIVEDVizzielli G, Fanfani F, Chiantera V, Tortorella L, Lucidi A, Petrillo M, Costantini B, Scambia G, Fagotti A. Does the diagnosis center influence the prognosis of ovarian cancer patients submitted to neoadjuvant chemotherapy? Anticancer Res. 2015 May;35(5):3027-32.
PMID: 25964591DERIVEDvan Meurs HS, Tajik P, Hof MH, Vergote I, Kenter GG, Mol BW, Buist MR, Bossuyt PM. Which patients benefit most from primary surgery or neoadjuvant chemotherapy in stage IIIC or IV ovarian cancer? An exploratory analysis of the European Organisation for Research and Treatment of Cancer 55971 randomised trial. Eur J Cancer. 2013 Oct;49(15):3191-201. doi: 10.1016/j.ejca.2013.06.013. Epub 2013 Jul 11.
PMID: 23850170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ignace B. Vergote, MD, PhD
U.Z. Gasthuisberg, Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
September 1, 1998
Primary Completion
January 1, 2009
Last Updated
August 5, 2015
Record last verified: 2013-08