To determine the diagnostic accuracy of FDG-PET-CT (pre-treatment and in the early phase of treatment) in the prediction of local control after primary radiotherapy with or without chemotherapy for functionally inoperable HNSCC.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of FDG-PET-CT applied 2 weeks after the start of primary
radiotherapy (with or without chemotherapy) for resectable HNSCC to predict
local failure in the primary and cervical node metastases.
Secondary outcome
* FDG uptake level pretreatment
* Residual FDG uptake level after 14 days of therapy
* Change of FDG uptake
.
Background summary
The last decade, radiotherapy with or without chemotherapy has been an upcoming
organ spearing treatment modality for functional inoperable head and neck
squamous cell carcinoma (HNSCC) to retain the best quality of life. An early
identification of nonresponders to (chemo)radiation would refrain a substantial
number of patients from the morbidity and costs of a futile extensive
treatment, the complications of salvage surgery and may improve survival due to
the remaining option of postoperative radiotherapy.
Study objective
To determine the diagnostic accuracy of FDG-PET-CT (pre-treatment and in the
early phase of treatment) in the prediction of local control after primary
radiotherapy with or without chemotherapy for functionally inoperable HNSCC.
Study design
Prospective, single institute observational study of 20 consecutive patients.
Study burden and risks
In current clinical practice these patients undergo PET-CT pretreatment. In
this protocol these patients will undergo one PET-CT extra (in the early phase
of treatment) due to the study. Radiation exposure due to repeated PET-CT
scanning (11 mSv) is negligible compared to the radiation therapy of these
patients.
These patients have no benefit of the extra PET-CT, as this PET-CT is not
reviewed until the end of the study. In the future patients may benefit from
PET during treatment in stopping futile (low chance to cure) (chemo)radiation
and switch to surgical treatment with still some adjuvant radiotherapy
available.
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
patients with resectable advanced (stage III and IV) HNSCC scheduled for primary non-surgical treatment (radiotherapy with or without chemotherapy) with curative intent.
Exclusion criteria
technically inoperable tumor
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 | NL20124.029.07 |