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

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ClinicalTrials.gov Identifier: NCT00003636
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.


Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: carboplatin Drug: cisplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 704 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
Study Start Date : September 1998
Actual Primary Completion Date : January 2009





Primary Outcome Measures :
  1. 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 :
  1. 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
  2. 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
  3. Toxicity as measured by NCIC Common Toxicity Criteria v2.0 within 4 weeks of surgery


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003636


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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003636     History of Changes
Other Study ID Numbers: EORTC-55971
EORTC-55971
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2013

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Carboplatin
Antineoplastic Agents