Carcinoma Oropharynx Radiotherapy
Conditions
Interventions
Additional adminsitration of cidofovir during the six weeks of radiotherapeutical treatment. Extra biopsy after 96 hours of the first cidofovir administration, if feasible.
Monitoring urine and serum
Sponsors
initiator = sponsor
Eligibility
Inclusion criteria
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. 3. WHO performance status 0-4
Exclusion criteria
Exclusion criteria: 1. More then 10% weight loss the last 6 months. 2. Abnormal serum bilirubin, white blood cells, neutrophils, platelets, hemoglobin. 3. Prior history of head or neck radiotherapy. 4. Uncontrolled infectious disease. 5. Unwilling and unable to comply with the study prescriptions. 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary objective: determining maximum tolerated dose of cidofovir in combination with radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactJ.M.J.A.A. Straetmans
University Hospital Maastricht P. Debyelaan 25
Outcome results
None listed