|- candidate number||4111|
|- NTR Number||NTR1456|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-sep-2008|
|- Secondary IDs||NL19517.068.07 |
|- Public Title||Antiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumors of the oropharynx|
|- Scientific Title||Antiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumors of the oropharynx|
|- hypothesis||1. Primary objective: determining maximum tolerated dose of cidofovir in combination with radiotherapy. |
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.
|- Healt Condition(s) or Problem(s) studied||Carcinoma, Radiotherapy, Oropharyngeal cancer, Antiviral therapy|
|- 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||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.
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-mrt-2009|
|- planned closingdate||28-feb-2010|
|- Target number of participants||12|
|- 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 for renal, liver function, full blood count weekly and monitoring vital parameters weekly during administration.|
|- Primary outcome||1. Primary objective: determining maximum tolerated dose of cidofovir in combination with radiotherapy.|
|- Secondary outcome||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. |
|- Timepoints||Starting one week before radiotherapy and weekly continuing adminstration of cidofovir for six weeks. |
Pet-CT scan after three months, Assessment of cohort untill four weeks after the last administration.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. J.M.J.A.A. Straetmans|
|- CONTACT for SCIENTIFIC QUERIES||Drs. J.M.J.A.A. Straetmans|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|University Hospital Maastricht (AZM)|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||25-sep-2008 - 1-okt-2008|