|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003636 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: cisplatin Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 704 |
| Study Start Date: | September 1998 |
OBJECTIVES:
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.
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| Argentina | |
| Hospital de Clinicas "Jose De San Martin" | |
| Buenos Aires, Argentina, 1120 | |
| Shaare Zedek Medical Center | |
| Buenos Aires, Argentina, 1120 | |
| Austria | |
| Allgemeines Krankenhaus - Universitatskliniken | |
| Vienna, Austria, A-1090 | |
| Innsbruck Universitaetsklinik | |
| Innsbruck, Austria, A-6020 | |
| Karl-Franzens-University Graz | |
| Graz, Austria, A-8010 | |
| 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 | |
| Cazk Groeninghe - Campus Maria's Voorzienigheid | |
| Kortrijk, Belgium, B-8500 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| 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 | |
| Hopital Notre-Dame du CHUM | |
| Montreal, Quebec, Canada, H4L 2M1 | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Denmark | |
| Herlev Hospital - University Hospital of Copenhagen | |
| Copenhagen, Denmark, DK-2730 | |
| France | |
| Centre Hospitalier Regional et Universitaire de Lille | |
| Lille, France, 59037 | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| 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 | |
| Azienda Sanitaria Ospedaliera Ordine Mauriziano | |
| Torino, Italy, 10128 | |
| Clinica Universitaria | |
| Turin, Italy, 10138 | |
| Libero Istituto Universitario Campus Bio-Medico | |
| Rome, Italy, 00155 | |
| Mirano General Hospital | |
| Mirano-Venice, Italy, 30035 | |
| Spedali Civili di Brescia | |
| Brescia, Italy, 25124 | |
| Netherlands | |
| Academisch Medisch Centrum at University of Amsterdam | |
| Amsterdam, Netherlands, 1105 AZ | |
| Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum | |
| Amsterdam, Netherlands, 1081 HV | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Erasmus MC - Sophia Children's Hospital | |
| Rotterdam, Netherlands, 3015 GJ | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1007 MB | |
| 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 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Universitario Central de Asturias | |
| Oviedo, Spain, 33006 | |
| Hospital Universitario San Carlos | |
| Madrid, Spain, 28040 | |
| Institut d'Oncologia Corachan | |
| Barcelona, Spain, 08.017 | |
| Sweden | |
| Karolinska University Hospital - Huddinge | |
| Stockholm, Sweden, S - 141 86 | |
| Lund University Hospital | |
| Lund, Sweden, SE-22185 | |
| Umea Universitet | |
| Umea, Sweden, SE-901 87 | |
| Uppsala University Hospital | |
| Uppsala, Sweden, SE-75185 | |
| United Kingdom | |
| Queen Elizabeth The Queen Mother Hospital | |
| Margate, United Kingdom, CT9 4AN | |
| United Kingdom, England | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| 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 | |
| Royal United Hospital | |
| Bath, England, United Kingdom, BA1 3NG | |
| Staffordshire General Hospital | |
| Stafford, England, United Kingdom, ST16 3SA | |
| University College of London Hospitals | |
| London, England, United Kingdom, WIT 3AA | |
| United Kingdom, Scotland | |
| Western Infirmary | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Investigator: | Ignace B. Vergote, MD, PhD | U.Z. Gasthuisberg |
More Information
| Study ID Numbers: | CDR0000066721, EORTC-55971 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003636 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
|
Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Cisplatin Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Peritoneal Neoplasms |