Hyperthermia and PARP-1 inhibition in recurrent head&neck or bladder cancer
Completed
- Conditions
- head and neck cancer and bladder cancer10027655
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is toxicity graded according to the International<br /><br>Common Toxicity Criteria (CTC), version 4.0.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The response rate of olaparib in combination with hyperthermia in patients with<br /><br>previously irradiated recurrent carcinoma of the head and neck or in patients<br /><br>with primary irresectable or recurrent bladder cancer unfit for or who<br /><br>progressed after platinum-based chemotherapy.<br /><br><br /><br>HRD induced by hyperthermia in vivo as measured by degradation of the BRCA2<br /><br>protein or decreased formation of RAD51 foci.</p><br>