CISPLATIN for Head and neck squamous cell carcinoma (locally advanced)

Inclusion criteria

• {"criterion_text":"-\tconsidered, eligible and planned for primary cisplatin CRT by treating physician\n-\teighteen years of age or older\n-\tsufficient understanding of Dutch and medical consequences to give informed consent."}

Exclusion criteria

• {"criterion_text":"-\tmentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent\n-\ta history of bilateral lymph node dissection in the neck and no available (PET-)CT scan of the third lumbar vertebra\n-\tan absolute contraindication for cisplatin as defined by the treating physician, including relevant pre-existing kidney insufficiency, clinically apparent vascular disease (for example claudicatio intermittens), clinically relevant perceptive deafness, serious neuropathy and poor performance score."}

Primary endpoints

• {"endpoint_text":"- The primary outcome parameter is compliance (non CDLT) rate to the proposed cisplatin scheme. Compliance to chemotherapy is defined as the absence of CDLT. CDLT is defined as any toxicity resulting in a cisplatin dose-reduction of ≥50%, a postponement of treatment of ≥4 days or a definite termination of cisplatin after the first or second cycle of therapy.","definition_or_measurement_approach":"Compliance to chemotherapy = absence of CDLT. CDLT defined as any toxicity resulting in a cisplatin dose-reduction of ≥50%, a postponement of treatment of ≥4 days or a definite termination of cisplatin after the first or second cycle of therapy."}

Secondary endpoints

• {"endpoint_text":"- Secondary outcome parameters are adverse events/toxicity, cumulative cisplatin dose, time to recurrence, 2-year overall survival, costs, quality of life and patient's preference. The main oncological outcome parameters are time to recurrence and survival. Clinically relevant treatment related toxicity parameters, including specific toxicity that results in significant (grade 3 or 4) toxicity, treatment de-escalation or termination, will be recorded by the treating medical oncologist.Toxicity wi","definition_or_measurement_approach":"Adverse events/toxicity graded according to CTCAE v5; cumulative cisplatin dose; time to recurrence; 2-year overall survival; costs and cost-effectiveness (measured using a Productivity Cost Questionnaire as stated in translated endpoint text); quality of life measured by questionnaires; clinically relevant treatment-related toxicity including grade 3 or 4 events, treatment de-escalation or termination will be recorded by treating medical oncologist."}

Netherlands

Earliest CTIS Part Ii Submission Date

31-10-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

11

Number Of Sites

5

Number Of Participants

160

Primary sponsor

Full Name

Universitair Medisch Centrum Utrecht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands