Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
NCT ID: NCT00003636
Last Updated: 2015-08-05
Study Results
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Basic Information
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COMPLETED
PHASE3
704 participants
INTERVENTIONAL
1998-09-30
Brief Summary
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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.
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Detailed Description
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* Compare the overall survival and progression-free survival in patients with stage IIIC or IV ovarian epithelial, peritoneal, or fallopian tube carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront cytoreductive surgery followed by chemotherapy with or without interval debulking surgery.
* Compare the quality of life of patients treated with these regimens.
* Compare the different treatment complications in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, method of biopsy, stage, largest tumor size before surgery, and intent to also randomize on EORTC-55012. Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo upfront maximal cytoreductive surgery followed by cisplatin or carboplatin IV every 3 weeks for 3 courses. Patients with non-optimal primary debulking may undergo interval debulking surgery at the physician's discretion. All patients then receive an additional 3 courses of the same regimen of chemotherapy.
* Arm II: Patients receive chemotherapy as in arm I. Patients with stable or responding disease undergo interval debulking surgery followed by an additional 3 courses of the same regimen of chemotherapy.
Second-look surgery is allowed for both arms if clinically indicated.
Quality of life (QOL) is assessed prior to treatment, after the third and sixth course of chemotherapy, and at 6 and 12 months after study. Patients who are also randomized on EORTC-55012 follow the QOL assessment schedule for EORTC-55012 only.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study within 4 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
cisplatin
conventional surgery
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
* If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true:
* Presence of pelvic ovarian mass
* Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis
* CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor)
* Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25)
* Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan
* No brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.25 times upper limit of normal (ULN)
Renal:
* Creatinine less than 1.25 times ULN
Other:
* No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy
* No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
* No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Ignace B. Vergote, MD, PhD
Role: STUDY_CHAIR
U.Z. Gasthuisberg, Leuven
Locations
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Hospital de Clinicas "Jose De San Martin"
Buenos Aires, , Argentina
Shaare Zedek Medical Center
Buenos Aires, , Argentina
Karl-Franzens-University Graz
Graz, , Austria
Innsbruck Universitaetsklinik
Innsbruck, , Austria
Allgemeines Krankenhaus - Universitatskliniken
Vienna, , Austria
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna, , Austria
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
Centre Hospitalier Regional et Universitaire de Lille
Lille, , France
Institut Claudius Regaud
Toulouse, , France
Martin Luther Universitaet
Halle, , Germany
Coombe Women's Hospital
Dublin, , Ireland
St. James's Hospital
Dublin, , Ireland
Spedali Civili di Brescia
Brescia, , Italy
Mirano General Hospital
Mirano-Venice, , Italy
Libero Istituto Universitario Campus Bio-Medico
Rome, , Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano
Torino, , Italy
Clinica Universitaria
Turin, , Italy
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
Erasmus MC - Sophia Children's Hospital
Rotterdam, , Netherlands
Haukeland Hospital - University of Bergen
Bergen, , Norway
Norwegian Radium Hospital
Oslo, , Norway
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
Lisbon, , Portugal
Institut d'Oncologia Corachan
Barcelona, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Lund University Hospital
Lund, , Sweden
Karolinska University Hospital - Huddinge
Stockholm, , Sweden
Umea Universitet
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Royal United Hospital
Bath, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, , United Kingdom
Countries
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References
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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.
Verleye 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.
Vergote 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.
Fruehauf 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.
Tajik 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.
Vizzielli 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.
van 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.
Other Identifiers
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EORTC-55971
Identifier Type: -
Identifier Source: secondary_id
EORTC-55971
Identifier Type: -
Identifier Source: org_study_id
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