History of Changes for Study: NCT00003636

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

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Study Record Versions

Version	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

Comparison Format:

Merged
Side-by-Side

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:	A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
Secondary IDs:	EORTC-55971

Study Status


Record Verification:	November 2006
Overall Status:	Active, not recruiting
Study Start:	September 1998
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:	May 21, 2011
Last Update Posted:	May 24, 2011 [Estimate]

Sponsor/Collaborators


Sponsor:	European Organisation for Research and Treatment of Cancer - EORTC
Responsible Party:
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:

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.

Conditions


Conditions:	Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer
Keywords:	stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:
Number of Arms:
Masking:	(masked roles unspecified)
Allocation:	Randomized
Enrollment:	704 [Anticipated]

Arms and Interventions


Intervention Details:
	Drug: carboplatin
	Drug: cisplatin
	Procedure: conventional surgery
	Procedure: neoadjuvant therapy

Outcome Measures


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

Eligibility


Minimum Age:
Maximum Age:
Sex:	Female
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

Contacts/Locations


Study Officials:	Ignace B. Vergote, MD, PhD University Hospital, Gasthuisberg
Locations:	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
	Queen Elizabeth The Queen Mother Hospital Margate, United Kingdom, CT9 4AN
	United Kingdom, England
	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
	United Kingdom, Scotland
	Western Infirmary Glasgow, Scotland, United Kingdom, G11 6NT

IPDSharing


Plan to Share IPD:

References


Citations:	[Study Results] Verleye L, Ottevanger PB, Kristensen GB, Ehlen T, Johnson N, van der Burg ME, Reed NS, Verheijen RH, Gaarenstroom KN, Mosgaard B, Seoane JM, van der Velden J, Lotocki R, van der Graaf W, Penninckx B, Coens C, Stuart G, Vergote I. Quality of pathology reports for advanced ovarian cancer: are we missing essential information? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial. Eur J Cancer. 2011 Jan;47(1):57-64. doi: 10.1016/j.ejca.2010.08.008. Epub 2010 Sep 16. PubMed 20850296
	[Study Results] Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806. PubMed 20818904
	[Study Results] 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.
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