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| ID | Type | Description | Link |
|---|---|---|---|
| MRC-OV05 | |||
| EORTC-55955 | |||
| ISRCTN87786644 |
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| Name | Class |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.
PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more than two times the upper limit of normal are randomized to one of two treatment arms.
Quality of life is assessed at baseline, at each follow-up visit, and, if treatment is instituted, before each chemotherapy course.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Benefit of early chemotherapy | ||
| Overall survival | ||
| Quality of life |
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DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
Prior participation in the following clinical trials is allowed:
No prior participation in MRC-ICON1 (adjuvant chemotherapy for early-stage ovarian cancer)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon J.S. Rustin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital | |
| M. E.L. van der Burg, MD, PhD | University Medical Center Rotterdam at Erasmus Medical Center |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Franz Josef Hospital | Vienna | A-1100 | Austria | |||
| Institut Jules Bordet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20215782 | Background | Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. No abstract available. | |
| 20888993 | Result | Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8. |
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| Brussels |
| 1000 |
| Belgium |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels | 1090 | Belgium |
| Cazk Groeninghe - Campus Maria's Voorzienigheid | Kortrijk | B-8500 | Belgium |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Coombe Women's Hospital | Dublin | 8 | Ireland |
| St. James' Hospital | Dublin | 8 | Ireland |
| Spedali Civili di Brescia | Brescia | 25124 | Italy |
| Academisch Medisch Centrum at University of Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Leiden University Medical Center | Leiden | 2300 RC | Netherlands |
| Nijmegen Cancer Center at Radboud University Medical Center | Nijmegen | NL-6500 HB | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| Leyenburg Ziekenhuis | The Hague | 2545 CH | Netherlands |
| University Medical Center Utrecht | Utrecht | 3508 GA | Netherlands |
| Isala Klinieken - locatie Sophia | Zwolle | 8000 GK | Netherlands |
| Hospitais da Universidade de Coimbra (HUC) | Coimbra | 3001-301 | Portugal |
| Groote Schuur Hospital | Cape Town | 7925 | South Africa |
| Institut d'Oncologia Corachan | Barcelona | 08017 | Spain |
| Hospital Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Result | Rustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Suppl 18): A-1, 2009. |
| 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 |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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