AzTrials
AzTrials

Fallopian Tube CancerPhase 3NCT00003636

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

A Phase 3 study testing carboplatin, cisplatin and conventional surgery in people with Fallopian Tube Cancer and Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 65 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
carboplatin, cisplatin and conventional surgery
Type of treatment
Surgery or procedure
How many people
704 participants
Where
65 sitesin 15 countries
Study dates
Sep 1998to Jan 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

65 sites in 15 countries.

65 sites in 15 countries

Canada12 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H4L 2M1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United Kingdom10 sites

  • Royal United Hospital

    Bath, England, BA1 3NG

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Western Infirmary

    Glasgow, Scotland, G11 6NT

  • University College of London Hospitals

    London, England, WIT 3AA

  • Queen Elizabeth The Queen Mother Hospital

    Margate, CT9 4AN

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

Other trials in United Kingdom

Netherlands8 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007 MB

  • Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

    Amsterdam, 1081 HV

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

  • Erasmus MC - Sophia Children's Hospital

    Rotterdam, 3015 GJ

Other trials in Netherlands

Italy5 sites

  • Spedali Civili di Brescia

    Brescia, 25124

  • Mirano General Hospital

    Mirano-Venice, 30035

  • Libero Istituto Universitario Campus Bio-Medico

    Rome, 00155

  • Azienda Sanitaria Ospedaliera Ordine Mauriziano

    Torino, 10128

  • Clinica Universitaria

    Turin, 10138

Other trials in Italy

Austria4 sites

  • Karl-Franzens-University Graz

    Graz, A-8010

  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

  • Allgemeines Krankenhaus - Universitatskliniken

    Vienna, A-1090

  • Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

    Vienna, A-1100

Other trials in Austria

Belgium4 sites

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Cazk Groeninghe - Campus Maria's Voorzienigheid

    Kortrijk, B-8500

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

France4 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Institut Claudius Regaud

    Toulouse, 31052

Other trials in France

Spain4 sites

  • Institut d'Oncologia Corachan

    Barcelona, 08.017

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

Other trials in Spain

Sweden4 sites

  • Lund University Hospital

    Lund, SE-22185

  • Karolinska University Hospital - Huddinge

    Stockholm, S - 141 86

  • Umea Universitet

    Umeå, SE-901 87

  • Uppsala University Hospital

    Uppsala, SE-75185

Other trials in Sweden

Argentina2 sites

  • Hospital de Clinicas "Jose De San Martin"

    Buenos Aires, 1120

  • Shaare Zedek Medical Center

    Buenos Aires, 1120

Other trials in Argentina

Ireland2 sites

  • Coombe Women's Hospital

    Dublin, 8

  • St. James's Hospital

    Dublin, 8

Other trials in Ireland

Norway2 sites

  • Haukeland Hospital - University of Bergen

    Bergen, N-5021

  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

Portugal2 sites

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

    Lisbon, 1099-023 Codex

Other trials in Portugal

Denmark1 site

  • Herlev Hospital - University Hospital of Copenhagen

    Copenhagen, DK-2730

Other trials in Denmark

Germany1 site

  • Martin Luther Universitaet

    Halle, D-06112

Other trials in Germany

About this study

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

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.

Read the 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.

Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually

Secondary outcomes (3)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 1998
  3. Primary completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
704 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003636
Sponsor's protocol ID
EORTC-55971
Other IDs
EORTC-55971
Status last verified
Aug 2013
First submitted
1 Nov 1999
Last updated
5 Aug 2015
Results posted
No

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.

    PubMed 21917306

  • 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

  • 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

  • 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.

  • Tajik P, van de Vrie R, Zafarmand MH, Coens C, Buist MR, Vergote I, Bossuyt PMM, Kenter GG. The FIGO Stage IVA Versus IVB of Ovarian Cancer: Prognostic Value and Predictive Value for Neoadjuvant Chemotherapy. Int J Gynecol Cancer. 2018 Mar;28(3):453-458. doi: 10.1097/IGC.0000000000001186.

    PubMed 29324537

  • Vizzielli G, Fanfani F, Chiantera V, Tortorella L, Lucidi A, Petrillo M, Costantini B, Scambia G, Fagotti A. Does the diagnosis center influence the prognosis of ovarian cancer patients submitted to neoadjuvant chemotherapy? Anticancer Res. 2015 May;35(5):3027-32.

    PubMed 25964591

  • van Meurs HS, Tajik P, Hof MH, Vergote I, Kenter GG, Mol BW, Buist MR, Bossuyt PM. Which patients benefit most from primary surgery or neoadjuvant chemotherapy in stage IIIC or IV ovarian cancer? An exploratory analysis of the European Organisation for Research and Treatment of Cancer 55971 randomised trial. Eur J Cancer. 2013 Oct;49(15):3191-201. doi: 10.1016/j.ejca.2013.06.013. Epub 2013 Jul 11.

    PubMed 23850170

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, cisplatin and conventional surgery in people with Fallopian Tube Cancer and Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 65 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Canada, United Kingdom, Netherlands, Italy, Austria and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003636, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.

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