No registrations found.
ID
Source
Brief title
Health condition
Carcinoma
Oropharynx
Radiotherapy
Sponsors and support
Intervention
Outcome measures
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.
Study objective
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.
Study design
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.
Intervention
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.
P. Debyelaan 25
J.M.J.A.A. Straetmans
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
jstra@skno.azm.nl
P. Debyelaan 25
J.M.J.A.A. Straetmans
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
jstra@skno.azm.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1396 |
| NTR-old | NTR1456 |
| CCMO | NL19517.068.07 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON33865 |