To investigate for patients with locally advanced HNSCC, the dynamics of tumour hypoxia during the course of radiotherapy/chemoradiation using 18F-FAZA PET-CT. To investigate the best strategy for gradual dose escalation. This may be done by using…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
hoofd hals kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tumour hypoxia prior and during the course of radiotherapy/chemoradiation using
18F-FAZA PET-CT for locally advanced HNSCC
Secondary outcome
To investigate tumour heterogeneity with 18F-FAZA PET-CT
More specifically, the following endpoints will be used:
* SUV hypoxia prior to therapy (SUV max, SUV70%) [Research 18F-FAZA PET scan]
* SUV hypoxia week 1 of therapy (SUV max, SUV70%) [Research 18F-FAZA PET scan]
* SUV hypoxia week 2 of therapy (SUV max, SUV70%) [Research 18F-FAZA PET scan]
* SUV hypoxia week 4 of therapy (SUV max, SUV70%) [Research 18F-FAZA PET
scan]
Background summary
A major cause of treatment failure of HNSCC is tumour hypoxia. Hypoxic cells
are resistant to the cytotoxic effects of both chemotherapy and ionizing
radiation.
A possible way to improve radiotherapy/chemoradiation results in locally
advanced HNSCC is to increase the radiation dose delivered to hypoxic areas
within the tumour. An image modality to visualize hypoxic areas, which can be
incorporated into the treatment plan, is 18F-FAZA PET-CT. Therefore, it is
hypothesized that 18F-FAZA PET-CT can be used to guide radiotherapy in order to
substantially increase the dose to hypoxic tumour sub-volumes. Unfortunately,
not much is known how these hypoxic sub-volumes behave during the course of the
radiotherapy/chemoradiation. Therefore much more data regarding possible
hypoxia changes during radiotherapy/chemoradiation is required before the
radiation dose can be safely increased.
Study objective
To investigate for patients with locally advanced HNSCC, the dynamics of tumour
hypoxia during the course of radiotherapy/chemoradiation using 18F-FAZA PET-CT.
To investigate the best strategy for gradual dose escalation. This may be done
by using IMRT with a simultaneous integrated boost (SIB), intensity modulated
arc therapy (IMAT), stereotactic boost (SRT) or protons.
Study design
Observational pilot study
Study burden and risks
Possible hematoma and pain at the place of injection.
Extra radiationd dose: patients receive extra dose per 18F-FAZA PET-CT scan of
6 mSv. For 4 18F-FAZA PET-CT scans, this will be about 24 mSv (= 24 mGy).
During the treatment, a patient will receive a total dose of 70.000 mGy
curative radiation. The extra radiation dose (24 mSv = 0.04%) exposure is
considered acceptable in relation to the prescribed radiation dose (70.000
MSv). In addition, it should be taken into account that the inaccuracy in the
dose calculation for the radiotherapy treatment is about 3% (= 2100 mSv). This
is 88 times the additional dose received from the 4 extra 18F-FAZA PET-CT
scans. Besides normal side effects due to the radiotherapy/chemoradiation, no
other toxicities are expected.
Duration of the 18F-FAZA PET-CT scan is 3 Hours (of which 2 hours is waiting
time). In totality this is 12 Hours Patients has to come one extra time to the
hospital. The other 3 18F-FAZA PET-CT scan will take place at times patients
are already in the hospital.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
* Intended curative primary (chemo)radiation for patients with locally advanced HNSCC.
* Age * 18 years.
* WHO performance status 0-2 (see appendix 1)
* Histological of cytological confirmation of HNSCC
* Locally advanced HNSCC (stage III-IV), TNM classification [8]
* Staging procedure should at least include CT-neck, MRI-neck and 18F-FDG-PET-scan
* Life expectancy of at least 6 months
* Planned for 35 x 2 Gy IMRT eventually with concomitant chemotherapy
* Absence 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.
* Before patient registration/randomisation, written informed consent must be given according to ICH/EU GCP, and national/local regulations.
Exclusion criteria
Not fullfilling the inclusioncriteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34936.042.11 |