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Data · dataset · 2024

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

Listed in IISH Dataverse

Cisplatin dose limiting toxicity (CDLT) occurs often and impedes obtaining the planned cumulative cisplatin dose.

Description

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.

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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.

The 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.

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Where it is published

Catalogue records · 1

Topics

Inferred from text
Cancer 75% · Disease 75% · Oncology and carcinogenesis 70%
Provenance · 1 source records, 12 field assertions
SourceKeyLast seenRaw
IISH Dataversedoi:10.34894/NBWOHU13 d agoJSON v1
FieldAssertionExtractorEvidence
concepts[disease].local:disease:cancerenrichment · datasets iisg amsterdamkeyword-concept-rules@1.0.0title+description (75%)
concepts[disease].local:disease:diseaseenrichment · datasets iisg amsterdamkeyword-concept-rules@1.0.0title+description (75%)
concepts[field].anzsrc:group:3211enrichment · datasets iisg amsterdamtaxonomy-embedding@1.1.0title+keywords+description (70%)
concepts[field].dataverse_subject:medicine-health-and-life-sciencessource · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0/subjects
concepts[field].local:field:life-sciencesmapping · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0/subjects
concepts[field].local:field:medicine-healthmapping · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0/subjects
created_datesource · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0
descriptionsource · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0/description
publication_datesource · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0
titlesource · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0/name
updated_datesource · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0
version_labelsource · datasets iisg amsterdamconnector:datasets_iisg_amsterdam@1.0.0