To determine if FDG PET/CT is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 head and neck…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal
involvement
Secondary outcome
1. The sensitivity and specificity of high-resolution FDG PET/CT
2. The sensitivity and specificity of dual time point FDG PET/CT
3. The number of additional distant metastases found on PET and the % change in
patient management
4. DFS and OS, correlation with baseline SUV, early PET response and with HPV
status
Background summary
In patients treated with chemoradiation for a head and neck tumor,
distinguishing between residual lymph node metastasis and radiotherapeutic
induced tissue damage can be difficult. Expectative follow up runs the risk of
treatment delay while a futile neck dissection induces morbidity and
costs.There is data to suggest that FDG-PET performed after completed
chemoradiation has adequate diagnostic accuracy to improve the selection of
patients for salvage neck dissection.
Study objective
To determine if FDG PET/CT is performant enough with respect to detecting
residual lymph node involvement after chemoradiation in order to omit planned
neck dissections in patients with locally advanced potentially operable, N2 and
N3 head and neck squamous cell carcinoma (HNSCC).
Study design
All patients will undergo a dedicated PET/CT protocol 12 weeks after the end of
chemoradiation (primary endpoint). In PET/CT negative patients, 2 monthly
control visits will be performed complemented with additional imaging as
required. All patients will undergo PET/CT 1 year after completing
chemoradiation unless recurrent/residual disease was already proven
pathologically. Patients with a PET/CT suspected for residual nodal disease
must have pathological proof of nodal involvement (fine needle aspiration in
non-operable patients or neck dissection in the others) before salvage surgery
is started.
In a subset of patients receiving induction chemotherapy prior to concurrent
chemoradiation, an additional PET scan will be performed at baseline and after
1 cycle of chemotherapy to evaluate the metabolic response to the treatment
(secondary endpoint).
Study burden and risks
Burden for patients is 2 PET-CT scans. Risks are neglectable.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
operable N2/N3 squamous cell carcinoma of head and neck
planned treatment of chemoradiation (with curative intent)
Exclusion criteria
Age < 18 years
Pregnancy
Physical condition contra-indication for neck dissection
Inoperable tumour in neck
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 | NL34141.029.10 |