Locally advanced head and neck squamous cell carcinoma
Conditions
Brief summary
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.
Detailed description
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
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed