TY - JOUR
T1 - 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
T2 - The CISLOW-study protocol
AU - Schaeffers, Anouk W M A
AU - Devriese, Lot A
AU - van Gils, Carla H
AU - Dankbaar, Jan Willem
AU - Voortman, Jens
AU - de Boer, Jan Paul
AU - Slingerland, Marije
AU - Hendriks, Mathijs P
AU - Smid, Ernst J
AU - Frederix, Geert W J
AU - de Bree, Remco
N1 - Funding Information: The Netherlands Organization for Health Research and Development (ZonMw), project number 10140021910002. The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2023 Schaeffers et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/11
Y1 - 2023/11
N2 - 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.
AB - 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.
KW - Antineoplastic Agents/adverse effects
KW - Chemoradiotherapy/adverse effects
KW - Cisplatin/adverse effects
KW - Head and Neck Neoplasms/drug therapy
KW - Humans
KW - Multicenter Studies as Topic
KW - Muscle, Skeletal/diagnostic imaging
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Squamous Cell Carcinoma of Head and Neck/drug therapy
UR - http://www.scopus.com/inward/record.url?scp=85178497631&partnerID=8YFLogxK
U2 - https://doi.org/10.1371/journal.pone.0294147
DO - https://doi.org/10.1371/journal.pone.0294147
M3 - Article
C2 - 38011186
SN - 1932-6203
VL - 18
SP - e0294147
JO - PLOS ONE
JF - PLOS ONE
IS - 11 November
M1 - e0294147
ER -