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","fileAccessRequest":false,"metadataBlocks":{"citation":{"displayName":"Citation Metadata","name":"citation","fields":[{"typeName":"title","multiple":false,"typeClass":"primitive","value":"Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiotherapy in head and neck cancer patients with low skeletal muscle mass"},{"typeName":"subtitle","multiple":false,"typeClass":"primitive","value":"21_329 CISLOW"},{"typeName":"otherId","multiple":true,"typeClass":"compound","value":[{"otherIdAgency":{"typeName":"otherIdAgency","multiple":false,"typeClass":"primitive","value":"Dutch Trial Register"},"otherIdValue":{"typeName":"otherIdValue","multiple":false,"typeClass":"primitive","value":"NL76533.041.21"}},{"otherIdAgency":{"typeName":"otherIdAgency","multiple":false,"typeClass":"primitive","value":"EU CT"},"otherIdValue":{"typeName":"otherIdValue","multiple":false,"typeClass":"primitive","value":"2024-514919-10-00"}}]},{"typeName":"author","multiple":true,"typeClass":"compound","value":[{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Anouk W.M.A. Schaeffers"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"University Medical Center Utrecht"},"authorIdentifierScheme":{"typeName":"authorIdentifierScheme","multiple":false,"typeClass":"controlledVocabulary","value":"ORCID"},"authorIdentifier":{"typeName":"authorIdentifier","multiple":false,"typeClass":"primitive","value":"0000-0002-7952-8734"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Nanouschka H. Maagdenberg"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"University Medical Center Utrecht"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Remco de Bree"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"University Medical Center Utrecht"}}]},{"typeName":"datasetContact","multiple":true,"typeClass":"compound","value":[{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"Datamanagement Imaging & Oncology"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"Anouk W.M.A. Schaeffers"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}}]},{"typeName":"dsDescription","multiple":true,"typeClass":"compound","value":[{"dsDescriptionValue":{"typeName":"dsDescriptionValue","multiple":false,"typeClass":"primitive","value":"Cisplatin dose limiting toxicity (CDLT) occurs often and impedes obtaining the planned cumulative cisplatin dose. A cumulative cisplatin dose of  200 mg/m2 or more is warranted for better survival and locoregional control. Patients with a low skeletal muscle mass (SMM) have a three-fold higher risk of developing CDLT than patients with a normal SMM. SMM can be assessed through measurements on routinely performed diagnostic head and neck CT- or MRI-scans. A weekly regimen of 40 mg/m2 body surface area cisplatin is proposed as a less toxic schedule, which possibly decreases the risk of developing CDLT and enables reaching a higher cumulative cisplatin dose. The aim of this multicenter randomized clinical trial (NL76533.041.21, registered in the Netherlands Trial Register) is to identify whether a regimen of weekly cisplatin increases compliance to the planned chemotherapy scheme in HNSCC patients with low SMM. The primary outcome is the difference in compliance rate, defined as absence of CDLT, between low SMM patients receiving either the weekly or triweekly regimen. Secondary outcomes consist of toxicities, the cumulative cisplatin dose, time to recurrence, incidence of recurrence at two years of follow-up, location of recurrence, 2-year overall, disease free and disease specific survival, quality of life, patient’s experiences, and cost-effectiveness.\n\nThe data are sensitive since they involve personal information of patients. There are also restrictions on use by commercial parties, and on sharing openly based on (inter)national laws and regulations and written informed consent. Therefore these data (and additional clinical data) are only available upon signing a Data Sharing Agreement (see Terms of Access) and within a specially designed environment provided by the UMC Utrecht."},"dsDescriptionDate":{"typeName":"dsDescriptionDate","multiple":false,"typeClass":"primitive","value":"2024-11-08"}}]},{"typeName":"subject","multiple":true,"typeClass":"controlledVocabulary","value":["Medicine, Health and Life Sciences"]},{"typeName":"keyword","multiple":true,"typeClass":"compound","value":[{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"chemoradiation"},"keywordVocabulary":{"typeName":"keywordVocabulary","multiple":false,"typeClass":"primitive","value":"chemoradiation"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"chemoradiotherapy"},"keywordVocabulary":{"typeName":"keywordVocabulary","multiple":false,"typeClass":"primitive","value":"chemoradiotherapy"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"cisplatin"},"keywordVocabulary":{"typeName":"keywordVocabulary","multiple":false,"typeClass":"primitive","value":"cisplatin"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"skeletal muscle mass"},"keywordVocabulary":{"typeName":"keywordVocabulary","multiple":false,"typeClass":"primitive","value":"skeletal muscle mass"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"dose limiting toxicity"},"keywordVocabulary":{"typeName":"keywordVocabulary","multiple":false,"typeClass":"primitive","value":"dose limiting toxicity"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"head and neck cancer"},"keywordVocabulary":{"typeName":"keywordVocabulary","multiple":false,"typeClass":"primitive","value":"head and neck cancer"}}]},{"typeName":"publication","multiple":true,"typeClass":"compound","value":[{"publicationCitation":{"typeName":"publicationCitation","multiple":false,"typeClass":"primitive","value":"Schaeffers AWMA, Devriese LA, van Gils CH, Dankbaar JW, Voortman J, de Boer JP, Slingerland M, Hendriks MP, Smid EJ, Frederix GWJ, de Bree R. Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiotherapy in head and neck cancer patients with low skeletal muscle mass: The CISLOW-study protocol. PLoS One. 2023 Nov 27;18(11):e0294147. doi: 10.1371/journal.pone.0294147. 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