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

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003636
• Collaborator: (none)
• Enrollment: 704
• Locations: 65
• Patients Per Site: 10.8

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Sep 1, 1998
• Actual Primary Completion Date: Jan 1, 2009

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 Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes 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:

• 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 and Locations

Locations

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

Sponsors and Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Chi DS, Musa F, Dao F, Zivanovic O, Sonoda Y, Leitao MM, Levine DA, Gardner GJ, Abu-Rustum NR, Barakat RR. An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT). Gynecol Oncol. 2012 Jan;124(1):10-4. doi: 10.1016/j.ygyno.2011.08.014. Epub 2011 Sep 13.

• Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
• ClinicalTrials.gov Identifier: NCT00003636
• Other Study ID Numbers: EORTC-55971; EORTC-55971
• First Posted: Jan 27, 2003
• Last Update Posted: Aug 5, 2015
• Last Verified: Aug 1, 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: Fallopian Tube Neoplasms; Carboplatin

Study Results

No Results Posted as of Aug 5, 2015