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| ID | Type | Description | Link |
|---|---|---|---|
| ENGOT-ov52/DGOG/OVHIPEC-2 | Other Identifier | European Network of Gynaecological Oncological trials Groups |
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stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional surgery | No Intervention | Primary cytoreductive surgery without HIPEC | |
| HIPEC | Experimental | Primary cytoreductive surgery with HIPEC with cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | HIPEC with cisplatin after cytoreductive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 1 year after last patient last visit |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence-free survival | 1 year after last patient last visit | |
| adverse events | toxicity of extra treatment compared standaard treatment | 30 days after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
ovarian cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| MSKCC New York |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32205449 | Derived | Koole S, van Stein R, Sikorska K, Barton D, Perrin L, Brennan D, Zivanovic O, Mosgaard BJ, Fagotti A, Colombo PE, Sonke G, Driel WJV; OVHIPEC-2 Steering Committee and the Dutch OVHIPEC group. Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial. Int J Gynecol Cancer. 2020 Jun;30(6):888-892. doi: 10.1136/ijgc-2020-001231. Epub 2020 Mar 23. |
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randomized controlled, open-label, multicenter phase III trial
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| cost evaluation | cost evaluation based measured by quality adjusted life year | 1 year after lplv |
| New York |
| New York |
| 10065 |
| United States |
| Rigshospitalet Copenhagen | Copenhagen | Denmark |
| CHU de Besancon | Besançon | France |
| Institut Bergonié | Bordeaux | France |
| o Institut Bergonié, Bordeaux | Bordeaux | France |
| CHU Lille | Lille | France |
| Centre Leon Berard, Lyon | Lyon | France |
| CHU Lyon | Lyon | France |
| Institut du Cancer Montpellier | Montpellier | France |
| Institut de Cancerologie de l'Ouest, ICO Nantes) | Nantes | France |
| Institut Curie Paris | Paris | France |
| CHRU Strasbourg | Strasbourg | France |
| Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse) | Toulouse | France |
| Mater Misericordiae University Hospital, Dublin | Dublin | Ireland |
| Policlinico Sant'Orsola, Bologna | Bologna | Italy |
| Fondazione Policlinico A Gemelli IRCCS | Roma | Italy |
| Antoni van leeuwenhoek | Amsterdam | North Holland | 1066CX | Netherlands |
| Amsterdam UMC | Amsterdam | Netherlands |
| Catharina Hospital | Eindhoven | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| UMCG | Groningen | Netherlands |
| Leiden University Medical Center (LUMC) | Leiden | Netherlands |
| Maastricht UMC+ | Maastricht | Netherlands |
| Radboud MC | Nijmegen | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| UMCU | Utrecht | Netherlands |
| Alice Bjoernlund-Larsen | Uppsala | Sweden |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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