Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer

August 4, 2015 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

704

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1120
        • Hospital de Clínicas "José de San Martín"
      • Buenos Aires, Argentina, 1120
        • Shaare Zedek Medical Center
  • Austria
      • Graz, Austria, A-8010
        • Karl-Franzens-University Graz
      • Innsbruck, Austria, A-6020
        • Innsbruck Universitaetsklinik
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus - Universitatskliniken
      • Vienna, Austria, A-1100
        • Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
  • Belgium
      • Brussels, Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus Maria's Voorzienigheid
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre - Calgary
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BCCA - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles LeMoyne
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill Cancer Centre at McGill University
      • Montreal, Quebec, Canada, H4L 2M1
        • Hopital Notre-Dame du CHUM
  • Denmark
      • Copenhagen, Denmark, DK-2730
        • Herlev Hospital - University Hospital of Copenhagen
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59037
        • Centre Hospitalier Regional et Universitaire de Lille
      • Toulouse, France, 31052
        • Institut Claudius Regaud
  • Germany
      • Halle, Germany, D-06112
        • Martin Luther Universitaet
  • Ireland
      • Dublin, Ireland, 8
        • St. James's Hospital
      • Dublin, Ireland, 8
        • Coombe Women's Hospital
  • Italy
      • Brescia, Italy, 25124
        • Spedali Civili di Brescia
      • Mirano-Venice, Italy, 30035
        • Mirano General Hospital
      • Rome, Italy, 00155
        • Libero Istituto Universitario Campus Bio-Medico
      • Torino, Italy, 10128
        • Azienda Sanitaria Ospedaliera Ordine Mauriziano
      • Turin, Italy, 10138
        • Clinica Universitaria
  • Netherlands
      • Amsterdam, Netherlands, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands, 1007 MB
        • Vrije Universiteit Medisch Centrum
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Amsterdam, Netherlands, 1081 HV
        • Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
      • Rotterdam, Netherlands, 3015 GJ
        • Erasmus MC - Sophia Children's Hospital
  • Norway
      • Bergen, Norway, N-5021
        • Haukeland Hospital - University of Bergen
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Portugal
      • Coimbra, Portugal, 3049
        • Hospitais da Universidade de Coimbra (HUC)
      • Lisbon, Portugal, 1099-023 Codex
        • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
  • Spain
      • Barcelona, Spain, 08.017
        • Institut d'Oncologia Corachan
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
      • Oviedo, Spain, 33006
        • Hospital Universitario Central de Asturias
  • Sweden
      • Lund, Sweden, SE-22185
        • Lund University Hospital
      • Stockholm, Sweden, S - 141 86
        • Karolinska University Hospital - Huddinge
      • Umea, Sweden, SE-901 87
        • Umeå universitet
      • Uppsala, Sweden, SE-75185
        • Uppsala University Hospital
  • United Kingdom
      • Margate, United Kingdom, CT9 4AN
        • Queen Elizabeth the Queen Mother Hospital
    • England
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • London, England, United Kingdom, WIT 3AA
        • University College of London Hospitals
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Stafford, England, United Kingdom, ST16 3SA
        • Staffordshire General Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Ignace B. Vergote, MD, PhD, U.Z. Gasthuisberg, Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-55971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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