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Antiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumors of the oropharynx


- candidate number4111
- NTR NumberNTR1456
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2008
- Secondary IDsNL19517.068.07 
- Public TitleAntiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumors of the oropharynx
- Scientific TitleAntiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumors of the oropharynx
- ACRONYMAntrhox
- hypothesis1. 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) studiedCarcinoma, Radiotherapy, Oropharyngeal cancer, Antiviral therapy
- Inclusion criteria1. 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 criteria1. 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 receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate28-feb-2010
- Target number of participants12
- InterventionsAdditional 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 outcome1. Primary objective: determining maximum tolerated dose of cidofovir in combination with radiotherapy.
- Secondary outcome2. 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.
- TimepointsStarting 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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. J.M.J.A.A. Straetmans
- CONTACT for SCIENTIFIC QUERIESDrs. J.M.J.A.A. Straetmans
- Sponsor/Initiator University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-sep-2008 - 1-okt-2008


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