Data management plan.
Chemoradiotherapy with cisplatin in a triweekly regimen of 100 mg/m2 body surface area, is used to treat locally advanced head and neck squamous cell carcinoma (HNSCC) with curative intent. 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 perfo... Mehr ...
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Dokumenttyp: | Text |
Erscheinungsdatum: | 2023 |
Schlagwörter: | Medicine / Cell Biology / Pharmacology / Immunology / Marine Biology / Cancer / Science Policy / Infectious Diseases / secondary outcomes consist / planned chemotherapy scheme / patient &# 8217 / netherlands trial register / less toxic schedule / xlink \ / > chemoradiotherapy / fold higher risk / disease specific survival / cumulative cisplatin dose / neck cancer patients / primary chemoradiotherapy / neck ct / disease free / better survival / year overall / two years / primary outcome / possibly decreases / occurs often / locoregional control / impedes obtaining / identify whether / enables reaching / curative intent / compliance rate / 40 mg / 200 mg / 100 mg |
Sprache: | unknown |
Permalink: | https://search.fid-benelux.de/Record/base-28785048 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://doi.org/10.1371/journal.pone.0294147.s005 |
Chemoradiotherapy with cisplatin in a triweekly regimen of 100 mg/m2 body surface area, is used to treat locally advanced head and neck squamous cell carcinoma (HNSCC) with curative intent. 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.