head and neck cancer and bladder cancer
Conditions
Interventions
Five hyperthermia treatment combined with olaparib twice daily
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Recurrent squamous cell carcinoma of the head and neck in previously irradiated area or primary irresectable stage T4 or a local recurrent bladder cancer (urothelial carcinoma or squamous cell carcinoma) in patients unfit for or who progressed after platinum-based chemotherapy and for whom no other treatments are available. • Age > 18 years • Performance status WHO 0-1 • Life expectancy of at least 3 months
Exclusion criteria
Exclusion criteria: Curative treatment options available • Treatment according to guideline available • Contra-indications for hyperthermia, i.e. patients with a pacemaker or metal implant in the heated area of > 2 cm , multiple sclerosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is toxicity graded according to the International Common Toxicity Criteria (CTC), version 4.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| The response rate of olaparib in combination with hyperthermia in patients with previously irradiated recurrent carcinoma of the head and neck or in patients with primary irresectable or recurrent bladder cancer unfit for or who progressed after platinum-based chemotherapy. HRD induced by hyperthermia in vivo as measured by degradation of the BRCA2 protein or decreased formation of RAD51 foci. | — |
Countries
Netherlands
Outcome results
None listed