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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-55971 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
| 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 |
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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:
Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan
No brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Ignace B. Vergote, MD, PhD | U.Z. Gasthuisberg, Leuven | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas "Jose De San Martin" | Buenos Aires | 1120 | Argentina | |||
| Shaare Zedek Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21917306 | Background | 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. | |
| 20850296 |
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| Toxicity as measured by NCIC Common Toxicity Criteria v2.0 within 4 weeks of surgery |
| Buenos Aires |
| 1120 |
| Argentina |
| Karl-Franzens-University Graz | Graz | A-8010 | Austria |
| Innsbruck Universitaetsklinik | Innsbruck | A-6020 | Austria |
| Allgemeines Krankenhaus - Universitatskliniken | Vienna | A-1090 | Austria |
| Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital | Vienna | A-1100 | Austria |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels | 1090 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| Cazk Groeninghe - Campus Maria's Voorzienigheid | Kortrijk | B-8500 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| BCCA - Fraser Valley Cancer Centre | Surrey | British Columbia | V3V 1Z2 | Canada |
| British Columbia Cancer Agency - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| CHUS-Hopital Fleurimont | Fleurimont | Quebec | J1H 5N4 | Canada |
| Hopital Charles Lemoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Hopital Notre-Dame du CHUM | Montreal | Quebec | H4L 2M1 | Canada |
| Herlev Hospital - University Hospital of Copenhagen | Copenhagen | DK-2730 | Denmark |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Hospitalier Regional et Universitaire de Lille | Lille | 59037 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Martin Luther Universitaet | Halle | D-06112 | Germany |
| Coombe Women's Hospital | Dublin | 8 | Ireland |
| St. James's Hospital | Dublin | 8 | Ireland |
| Spedali Civili di Brescia | Brescia | 25124 | Italy |
| Mirano General Hospital | Mirano-Venice | 30035 | Italy |
| Libero Istituto Universitario Campus Bio-Medico | Rome | 00155 | Italy |
| Azienda Sanitaria Ospedaliera Ordine Mauriziano | Torino | 10128 | Italy |
| Clinica Universitaria | Turin | 10138 | Italy |
| Vrije Universiteit Medisch Centrum | Amsterdam | 1007 MB | Netherlands |
| Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Academisch Medisch Centrum at University of Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Leiden University Medical Center | Leiden | 2300 CA | Netherlands |
| Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| Erasmus MC - Sophia Children's Hospital | Rotterdam | 3015 GJ | Netherlands |
| Haukeland Hospital - University of Bergen | Bergen | N-5021 | Norway |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| Hospitais da Universidade de Coimbra (HUC) | Coimbra | 3049 | Portugal |
| Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A. | Lisbon | 1099-023 Codex | Portugal |
| Institut d'Oncologia Corachan | Barcelona | 08.017 | Spain |
| Hospital Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33006 | Spain |
| Lund University Hospital | Lund | SE-22185 | Sweden |
| Karolinska University Hospital - Huddinge | Stockholm | S - 141 86 | Sweden |
| Umea Universitet | UmeƄ | SE-901 87 | Sweden |
| Uppsala University Hospital | Uppsala | SE-75185 | Sweden |
| Royal United Hospital | Bath | England | BA1 3NG | United Kingdom |
| Cheltenham General Hospital | Cheltenham | England | GL53 7AN | United Kingdom |
| University College of London Hospitals | London | England | WIT 3AA | United Kingdom |
| Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | CH63 4JY | United Kingdom |
| James Cook University Hospital | Middlesbrough | England | TS4 3BW | United Kingdom |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Nottingham City Hospital NHS Trust | Nottingham | England | NG5 1PB | United Kingdom |
| Staffordshire General Hospital | Stafford | England | ST16 3SA | United Kingdom |
| Western Infirmary | Glasgow | Scotland | G11 6NT | United Kingdom |
| Queen Elizabeth The Queen Mother Hospital | Margate | CT9 4AN | United Kingdom |
| Result |
| 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. |
| 20818904 | Result | 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. |
| Result | 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. |
| 29324537 | Derived | 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. |
| 25964591 | Derived | 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. |
| 23850170 | Derived | 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. |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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