Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study
Improvement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurr...
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| Veröffentlicht in: | BMC cancer 2014-01, Vol.14 (1), p.22-22, Article 22 |
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| creator | van de Laar, Rafli Zusterzeel, Petra L M Van Gorp, Toon Buist, Marrije R van Driel, Willemien J Gaarenstroom, Katja N Arts, Henriette J G van Huisseling, Johannes C M Hermans, Ralph H M Pijnenborg, Johanna M A Schutter, Eltjo M J Pelikan, Harold M P Vollebergh, Jos H A Engelen, Mirjam J A Inthout, Joanna Kruitwagen, Roy F P M Massuger, Leon F A G |
| description | Improvement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence.
Multicentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.
Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer. |
| doi_str_mv | 10.1186/1471-2407-14-22 |
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Multicentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.
Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.</description><identifier>ISSN: 1471-2407</identifier><identifier>EISSN: 1471-2407</identifier><identifier>DOI: 10.1186/1471-2407-14-22</identifier><identifier>PMID: 24422892</identifier><language>eng</language><publisher>England: BioMed Central</publisher><subject>Administration, Intravenous ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Cancer therapies ; Carcinoma, Ovarian Epithelial ; Chemotherapy ; Chemotherapy, Adjuvant ; Clinical Protocols ; Disease-Free Survival ; Drug Administration Schedule ; Ethics ; Female ; Hospitals ; Humans ; Informed consent ; Morbidity ; Mortality ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Neoplasms, Glandular and Epithelial - drug therapy ; Neoplasms, Glandular and Epithelial - mortality ; Neoplasms, Glandular and Epithelial - pathology ; Neoplasms, Glandular and Epithelial - surgery ; Netherlands ; Ovarian cancer ; Ovarian Neoplasms - drug therapy ; Ovarian Neoplasms - mortality ; Ovarian Neoplasms - pathology ; Ovarian Neoplasms - surgery ; Ovariectomy - adverse effects ; Ovariectomy - mortality ; Platinum Compounds - administration & dosage ; Platinum Compounds - adverse effects ; Research Design ; Soccer ; Studies ; Study Protocol ; Surgery ; Time Factors ; Treatment Outcome</subject><ispartof>BMC cancer, 2014-01, Vol.14 (1), p.22-22, Article 22</ispartof><rights>2014 van de Laar et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</rights><rights>Copyright © 2014 van de Laar et al.; licensee BioMed Central Ltd. 2014 van de Laar et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c454t-f400ec05c94932716556b14b70c63576df66d98ecbd45d00636a647755dc824a3</citedby><cites>FETCH-LOGICAL-c454t-f400ec05c94932716556b14b70c63576df66d98ecbd45d00636a647755dc824a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897943/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897943/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24422892$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van de Laar, Rafli</creatorcontrib><creatorcontrib>Zusterzeel, Petra L M</creatorcontrib><creatorcontrib>Van Gorp, Toon</creatorcontrib><creatorcontrib>Buist, Marrije R</creatorcontrib><creatorcontrib>van Driel, Willemien J</creatorcontrib><creatorcontrib>Gaarenstroom, Katja N</creatorcontrib><creatorcontrib>Arts, Henriette J G</creatorcontrib><creatorcontrib>van Huisseling, Johannes C M</creatorcontrib><creatorcontrib>Hermans, Ralph H M</creatorcontrib><creatorcontrib>Pijnenborg, Johanna M A</creatorcontrib><creatorcontrib>Schutter, Eltjo M J</creatorcontrib><creatorcontrib>Pelikan, Harold M P</creatorcontrib><creatorcontrib>Vollebergh, Jos H A</creatorcontrib><creatorcontrib>Engelen, Mirjam J A</creatorcontrib><creatorcontrib>Inthout, Joanna</creatorcontrib><creatorcontrib>Kruitwagen, Roy F P M</creatorcontrib><creatorcontrib>Massuger, Leon F A G</creatorcontrib><title>Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study</title><title>BMC cancer</title><addtitle>BMC Cancer</addtitle><description>Improvement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence.
Multicentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.
Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.</description><subject>Administration, Intravenous</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Cancer therapies</subject><subject>Carcinoma, Ovarian Epithelial</subject><subject>Chemotherapy</subject><subject>Chemotherapy, Adjuvant</subject><subject>Clinical Protocols</subject><subject>Disease-Free Survival</subject><subject>Drug Administration Schedule</subject><subject>Ethics</subject><subject>Female</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Informed consent</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Neoplasm Recurrence, Local</subject><subject>Neoplasm Staging</subject><subject>Neoplasms, Glandular and Epithelial - 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Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence.
Multicentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.
Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.</abstract><cop>England</cop><pub>BioMed Central</pub><pmid>24422892</pmid><doi>10.1186/1471-2407-14-22</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | BMC cancer, 2014-01, Vol.14 (1), p.22-22, Article 22 |
| issn | 1471-2407 1471-2407 |
| language | eng |
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| source | Electronic Journals Library; MEDLINE; DOAJ Directory of Open Access Journals; SpringerLink Journals; PubMed Central; PubMed Central Open Access; Springer Nature OA Free Journals |
| subjects | Administration, Intravenous Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Cancer therapies Carcinoma, Ovarian Epithelial Chemotherapy Chemotherapy, Adjuvant Clinical Protocols Disease-Free Survival Drug Administration Schedule Ethics Female Hospitals Humans Informed consent Morbidity Mortality Neoplasm Recurrence, Local Neoplasm Staging Neoplasms, Glandular and Epithelial - drug therapy Neoplasms, Glandular and Epithelial - mortality Neoplasms, Glandular and Epithelial - pathology Neoplasms, Glandular and Epithelial - surgery Netherlands Ovarian cancer Ovarian Neoplasms - drug therapy Ovarian Neoplasms - mortality Ovarian Neoplasms - pathology Ovarian Neoplasms - surgery Ovariectomy - adverse effects Ovariectomy - mortality Platinum Compounds - administration & dosage Platinum Compounds - adverse effects Research Design Soccer Studies Study Protocol Surgery Time Factors Treatment Outcome |
| title | Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-01T06%3A59%3A39IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Cytoreductive%20surgery%20followed%20by%20chemotherapy%20versus%20chemotherapy%20alone%20for%20recurrent%20platinum-sensitive%20epithelial%20ovarian%20cancer%20(SOCceR%20trial):%20a%20multicenter%20randomised%20controlled%20study&rft.jtitle=BMC%20cancer&rft.au=van%20de%20Laar,%20Rafli&rft.date=2014-01-14&rft.volume=14&rft.issue=1&rft.spage=22&rft.epage=22&rft.pages=22-22&rft.artnum=22&rft.issn=1471-2407&rft.eissn=1471-2407&rft_id=info:doi/10.1186/1471-2407-14-22&rft_dat=%3Cproquest_pubme%3E3185003821%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1482035139&rft_id=info:pmid/24422892&rfr_iscdi=true |