Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00003636
- 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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 704
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (65)
University College of London Hospitals
🇬🇧London, England, United Kingdom
Doctor H. Bliss Murphy Cancer Centre
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Allgemeines Krankenhaus - Universitatskliniken
🇦🇹Vienna, Austria
Karolinska University Hospital - Huddinge
🇸🇪Stockholm, Sweden
Libero Istituto Universitario Campus Bio-Medico
🇮🇹Rome, Italy
Karl-Franzens-University Graz
🇦🇹Graz, Austria
Hopital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
Shaare Zedek Medical Center
🇦🇷Buenos Aires, Argentina
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Spedali Civili di Brescia
🇮🇹Brescia, Italy
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Hospital de Clinicas "Jose De San Martin"
🇦🇷Buenos Aires, Argentina
Centre Oscar Lambret
🇫🇷Lille, France
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Centre Hospitalier Regional et Universitaire de Lille
🇫🇷Lille, France
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
St. James's Hospital
🇮🇪Dublin, Ireland
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Erasmus MC - Sophia Children's Hospital
🇳🇱Rotterdam, Netherlands
Umea Universitet
🇸🇪Umea, Sweden
Azienda Sanitaria Ospedaliera Ordine Mauriziano
🇮🇹Torino, Italy
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut d'Oncologia Corachan
🇪🇸Barcelona, Spain
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
🇳🇱Amsterdam, Netherlands
Lund University Hospital
🇸🇪Lund, Sweden
Haukeland Hospital - University of Bergen
🇳🇴Bergen, Norway
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospitais da Universidade de Coimbra (HUC)
🇵🇹Coimbra, Portugal
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, United Kingdom
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Copenhagen, Denmark
Mirano General Hospital
🇮🇹Mirano-Venice, Italy
Clinica Universitaria
🇮🇹Turin, Italy
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Martin Luther Universitaet
🇩🇪Halle, Germany
Institut Bergonie
🇫🇷Bordeaux, France
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Coombe Women's Hospital
🇮🇪Dublin, Ireland
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
🇵🇹Lisbon, Portugal
British Columbia Cancer Agency - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada