ClinicalTrials.gov

History of Changes for Study: NCT00003636
Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
Latest version (submitted August 4, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 August 2, 2005 Contacts/Locations and Study Status
3 September 8, 2005 Contacts/Locations, Study Status and Study Identification
4 December 6, 2005 References, Conditions and Study Status
5 January 12, 2006 Study Status and Contacts/Locations
6 February 23, 2006 References, Contacts/Locations and Study Status
7 March 29, 2006 Contacts/Locations and Study Status
8 May 2, 2006 Contacts/Locations and Study Status
9 May 23, 2006 Study Status
10 June 7, 2006 Study Status
11 June 8, 2006 Contacts/Locations and Study Status
12 August 3, 2006 Contacts/Locations and Study Status
13 September 6, 2006 Study Status and Contacts/Locations
14 September 29, 2006 Contacts/Locations and Study Status
15 November 8, 2006 Study Design, Conditions, Study Status, References, Contacts/Locations, Eligibility, Outcome Measures and Study Identification
16 December 4, 2006 Study Status and Contacts/Locations
17 January 11, 2007 Study Status
18 January 18, 2007 Recruitment Status, Study Status and Contacts/Locations
19 February 20, 2007 Study Status, References and Eligibility
20 March 5, 2007 References, Eligibility and Study Status
21 October 26, 2007 References, Arms and Interventions and Study Status
22 November 17, 2007 References and Study Status
23 December 25, 2007 Study Status
24 May 23, 2008 Arms and Interventions and Study Status
25 July 23, 2008 Study Design and Study Status
26 February 6, 2009 Study Status
27 September 11, 2010 References and Study Status
28 October 12, 2010 References and Study Status
29 April 23, 2011 Conditions and Study Status
30 May 21, 2011 Study Status
31 November 18, 2011 References and Study Status
32 March 5, 2012 Study Identification, Contacts/Locations, Study Status, Oversight and Sponsor/Collaborators
33 August 26, 2013 Study Status and Oversight
34 August 4, 2015 Recruitment Status, Study Status and Study Design
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Study NCT00003636
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000066721
Brief Title: Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
Official Title: Phase III Randomized Study of Neoadjuvant Chemotherapy Followed By Interval Debulking Surgery Versus Upfront Cytoreductive Surgery Followed By Chemotherapy With or Without Interval Debulking Surgery in Patients With Stage IIIC or IV Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Secondary IDs: EORTC-55971
NCT00003636
Open or close this module Study Status
Record Verification: March 2005
Overall Status: Recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: November 1, 1999
First Submitted that
Met QC Criteria:
January 26, 2003
First Posted: January 27, 2003 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Fallopian Tube Cancer
peritoneal cavity cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: carboplatin
Drug: cisplatin
Procedure: chemotherapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: surgery
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 0 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Ignace B. Vergote, MD, PhD
University Hospital, Gasthuisberg
Locations: Argentina
Hospital de Clinicas "Jose De San Martin"
[Recruiting]
Buenos Aires, Argentina, 1120
Contact:Contact: Contact Person 54-11-5950-8000
Shaare Zedek Medical Center
[Recruiting]
Buenos Aires, Argentina, 1120
Contact:Contact: Contact Person 972-2-655-5111
Austria
Karl-Franzens-University Graz
[Recruiting]
Graz, Austria, A-8010
Contact:Contact: Contact Person 43-316-380-4100
Innsbruck Universitaetsklinik
[Recruiting]
Innsbruck, Austria, A-6020
Contact:Contact: Contact Person 43-5122-504-2970
Allgemeines Krankenhaus der Stadt Wien
[Recruiting]
Vienna, Austria, A-1090
Contact:Contact: Contact Person 43-1-40-400
Kaiser Franz Josef Hospital
[Recruiting]
Vienna, Austria, A-1100
Contact:Contact: Contact Person 43-1-601-9152
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
[Recruiting]
Brussels, Belgium, 1090
Contact:Contact: Contact Person 32-2-477-6040
Universitair Ziekenhuis Antwerpen
[Recruiting]
Edegem, Belgium, B-2650
Contact:Contact: Contact Person 32-3-821-3000
Cazk Groeninghe - Campus Maria's Voorzienigheid
[Recruiting]
Kortrijk, Belgium, B-8500
Contact:Contact: Contact Person 32-562-34-211
U.Z. Gasthuisberg
[Recruiting]
Leuven, Belgium, B-3000
Contact:Contact: Contact Person 32-16-33-2211
Canada, Alberta
Tom Baker Cancer Centre - Calgary
[Recruiting]
Calgary, Alberta, Canada, T2N 4N2
Contact:Contact: Contact Person 403-270-1700
Canada, British Columbia
Fraser Valley Cancer Centre at British Columbia Cancer Agency
[Recruiting]
Surrey, British Columbia, Canada, V3V 1Z2
Contact:Contact: Contact Person 604-930-4060
British Columbia Cancer Agency - Vancouver Cancer Centre
[Recruiting]
Vancouver, British Columbia, Canada, V5Z 4E6
Contact:Contact: Contact Person 604-877-6000
Canada, Manitoba
CancerCare Manitoba
[Recruiting]
Winnipeg, Manitoba, Canada, R3E 0V9
Contact:Contact: Contact Person 204-787-2241
Canada, New Brunswick
Saint John Regional Hospital
[Recruiting]
Saint John, New Brunswick, Canada, E2L 4L2
Contact:Contact: Contact 506-648-6884
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
[Recruiting]
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Contact:Contact: Contact Person 709-777-6480
Canada, Nova Scotia
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
[Recruiting]
Halifax, Nova Scotia, Canada, B3H 1V7
Contact:Contact: Contact Person 902-473-6000
Canada, Ontario
Cancer Centre of Southeastern Ontario
[Recruiting]
Kingston, Ontario, Canada, K7L 5P9
Contact:Contact: Contact Person 613-544-2630
Canada, Quebec
CHUS-Hopital Fleurimont
[Recruiting]
Fleurimont, Quebec, Canada, J1H 5N4
Contact:Contact: Contact Person 819-346-1110
Hopital Charles Lemoyne
[Recruiting]
Greenfield Park, Quebec, Canada, J4V 2H1
Contact:Contact: Contact Person 514-466-5000
McGill Cancer Centre at McGill University
[Recruiting]
Montreal, Quebec, Canada, H2W 1S6
Contact:Contact: Contact Person 514-398-1444
Hopital Notre- Dame du CHUM
[Recruiting]
Montreal, Quebec, Canada, H4L 2M1
Contact:Contact: Contact Person 514-890-8000
Denmark
Herlev Hospital - University Hospital of Copenhagen
[Recruiting]
Copenhagen, Denmark, DK-2730
Contact:Contact: Contact Person 45-44-88-3499
France
Institut Bergonie
[Recruiting]
Bordeaux, France, 33076
Contact:Contact: Contact Person 33-556-333-333
Centre Oscar Lambret
[Recruiting]
Lille, France, 59020
Contact:Contact: Contact Person 33-320-295-959
Institut Claudius Regaud
[Recruiting]
Toulouse, France, 31052
Contact:Contact: Contact Person 33-5-61-424-242
Germany
Martin Luther Universitaet
[Recruiting]
Halle, Germany, D-06112
Contact:Contact: Contact Person 49-345-5570
Ireland
Coombe Women's Hospital
[Recruiting]
Dublin, Ireland, 8
Contact:Contact: Contact Person 353-1-408-5200
St. James's Hospital
[Recruiting]
Dublin, Ireland, 8
Contact:Contact: Contact Person 353-1-410-3756
Italy
Spedali Civili
[Recruiting]
Brescia, Italy, 25124
Contact:Contact: Contact Person 39-30-399-5483
Mirano General Hospital
[Recruiting]
Mirano-Venice, Italy, 30035
Contact:Contact: Contact Person 39-41-579-4111
Libero Istituto Universitario Campus Bio-Medico
[Recruiting]
Rome, Italy, 00155
Contact:Contact: Contact Person 39-6-2254-1366
Azienda Sanitaria Ospedaliera Ordine Mauriziano
[Recruiting]
Torino, Italy, 10128
Contact:Contact: Contact Person 39-11-508-1111
Clinica Universita
[Recruiting]
Turin, Italy, 10138
Contact:Contact: Contact Person 39-011-434-5345
Netherlands
Vrije Universiteit Medisch Centrum
[Recruiting]
Amsterdam, Netherlands, 1007 MB
Contact:Contact: Contact Person 31-20-444-4444
Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
[Recruiting]
Amsterdam, Netherlands, 1081 HV
Contact:Contact: Contact Person 31-20-444-4444
Onze Lieve Vrouwe Gasthuis
[Recruiting]
Amsterdam, Netherlands, 1091 HA
Contact:Contact: Contact Person 31-20-599-9111
Academisch Medisch Centrum at University of Amsterdam
[Recruiting]
Amsterdam, Netherlands, 1105 AZ
Contact:Contact: Contact Person 31-20-566-9111
Leiden University Medical Center
[Recruiting]
Leiden, Netherlands, 2300 CA
Contact:Contact: Contact Person 31-71-52-6911
Nijmegen Cancer Center at Radboud University Medical Center
[Recruiting]
Nijmegen, Netherlands, NL-6500 HB
Contact:Contact: Contact Person 31-24-361-1111
Daniel Den Hoed Cancer Center at Erasmus Medical Center
[Recruiting]
Rotterdam, Netherlands, 3008 AE
Contact:Contact: Contact Person 31-10-463-9222
Erasmus MC - Sophia Children's Hospital
[Recruiting]
Rotterdam, Netherlands, 3015 GJ
Contact:Contact: Contact Person 31-10-463-6363
Norway
Norwegian Radium Hospital
[Recruiting]
Oslo, Norway, N-0310
Contact:Contact: Contact Person 47-22-93-4000
Portugal
Hospitais da Universidade de Coimbra (HUC)
[Recruiting]
Coimbra, Portugal, 3049
Contact:Contact: Contact Person 351-239-403-939
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
[Recruiting]
Lisbon, Portugal, 1099-023 Codex
Contact:Contact: Contact Person 351-21-722-9800
Spain
Institut d'Oncologia Corachan
[Recruiting]
Barcelona, Spain, 08.017
Contact:Contact: Contact Person 34-931-280-0022
Hospital Universitario San Carlos
[Recruiting]
Madrid, Spain, 28040
Contact:Contact: Contact Person 34-913-330-3000
Hospital Universitario 12 de Octubre
[Recruiting]
Madrid, Spain, 28041
Contact:Contact: Contact Person 34-913-390-8003
Hospital Central de Asturias
[Recruiting]
Oviedo, Spain, 33006
Contact:Contact: Contact Person 34-98-510-6100
Sweden
Lund University Hospital
[Recruiting]
Lund, Sweden, SE-22185
Contact:Contact: Contact Person 46-46-177-506
Karolinska University Hospital - Huddinge
[Recruiting]
Stockholm, Sweden, S - 141 86
Contact:Contact: Contact Person 46-8-585-82439
Uppsala University Hospital
[Recruiting]
Uppsala, Sweden, SE-75185
Contact:Contact: Contact Person 46-18-611-0000
United Kingdom
Queen Elizabeth The Queen Mother Hospital
[Recruiting]
Margate, United Kingdom, CT9 4AN
Contact:Contact: Contact Person 44-1843-225-544
United Kingdom, England
Royal United Hospital
[Recruiting]
Bath, England, United Kingdom, BA1 3NG
Contact:Contact: Contact Person 44-255-824-317
Cheltenham General Hospital
[Recruiting]
Cheltenham, England, United Kingdom, GL53 7AN
Contact:Contact: Contact Person 44-1242-222-222
Meyerstein Institute of Oncology at University College of London Hospitals
[Recruiting]
London, England, United Kingdom, WIT 3AA
Contact:Contact: Contact Person 44-20-7436-6464
Clatterbridge Centre for Oncology NHS Trust
[Recruiting]
Merseyside, England, United Kingdom, CH63 4JY
Contact:Contact: Contact Person 44-151-334-1155
James Cook University Hospital
[Recruiting]
Middlesbrough, England, United Kingdom, TS4 3BW
Contact:Contact: Contact Person 44-1642-850-850
Mount Vernon Hospital
[Recruiting]
Northwood, England, United Kingdom, HA6 2RN
Contact:Contact: Contact Person 44-1923-826-111
Nottingham City Hospital NHS Trust
[Recruiting]
Nottingham, England, United Kingdom, NG5 1PB
Contact:Contact: Contact Person 44-115-969-1169
Staffordshire General Hospital
[Recruiting]
Stafford, England, United Kingdom, ST16 3SA
Contact:Contact: Contact Person
United Kingdom, Scotland
Western Infirmary
[Recruiting]
Glasgow, Scotland, United Kingdom, G11 6NT
Contact:Contact: Contact Person 44-141-211-2000
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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.
Links:
Available IPD/Information:

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