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…
ID
Bron
Verkorte titel
Aandoening
Carcinoma
Oropharynx
Radiotherapy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Primary objective: determining maximum tolerated dose of cidofovir in combination with radiotherapy.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
P. Debyelaan 25
J.M.J.A.A. Straetmans
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
jstra@skno.azm.nl
Wetenschappelijk
P. Debyelaan 25
J.M.J.A.A. Straetmans
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
jstra@skno.azm.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1396 |
| NTR-old | NTR1456 |
| CCMO | NL19517.068.07 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON33865 |