Locally advanced head and neck squamous cell carcinoma
Conditions
Interventions
None listed
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: - considered eligible and planned for primary cisplatin CRT by treating physician; - eighteen years of age or older; - sufficient understanding of Dutch and medical consequences to give informed consent.
Exclusion criteria
Exclusion criteria: - mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent; - a history of bilateral lymph node dissection in the neck and no available (PET-)CT scan of the third lumbal vertebra; - an absolute contraindication for cisplatin as defined by the treating physician, including relevant pre-existingkidney insufficiency, clinically apparent vascular disease (for example claudicatio intermittens), clinically relevant perceptive deafness, serious neuropathy and poor performance score. - an absolute contraindication for high dose three-weekly cisplatin 100 mg/m2 as defined by the treating physician; - interval between diagnostic scan and planned CRT >2 months; - cisplatin CRT planned as non-primary or induction treatment.
Design outcomes
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 will be scored according to theCommon Terminology Criteria for Adverse Events (CTCAE) guidelines, v5.0. | — |
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. | — |
Contacts
Public ContactAnouk Schaeffers
UMC Utrecht
Outcome results
None listed