Antiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumors of the oropharynx
- Conditions
- CarcinomaOropharynxRadiotherapy
- Registration Number
- NL-OMON27994
- Lead Sponsor
- initiator = sponsor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Histological proven HPV-positive carcinoma of the oropharynx in the dose escalating schedule.
2. UICC TNM I-IV, for which curable (high dosing) radiotherapy is advised.
Exclusion Criteria
1. More then 10% weight loss the last 6 months.
2. Abnormal serum bilirubin, white blood cells, neutrophils, platelets, hemoglobin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Primary objective: determining maximum tolerated dose of cidofovir in combination with radiotherapy.
- Secondary Outcome Measures
Name Time Method 2. Secundary objective: observation of tumor response by means of changement of HPV, p16 and p53 activity and by PET-CT scanning on tumoral gross volume 3 weeks before and after treatment.