Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma
18 Years
80 Years
Both
Head and Neck Squamous Cell Carcinoma
Trial Information
Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma
- The primary objective is to assess the negative predictive value (NPV) of PET as a single
examination in correctly predicting the absence of remaining invaded lymph nodes after
chemoradiotherapy for advanced HNSCC.
Secondary objectives include :
- The evaluation of the suitability of a wait and see approach without neck dissection
in patients considered as complete responders ( based on clinical evaluation and
imaging assessment including PET : all these diagnosis tools should be negative to
consider a patient as a complete responder); this suitability will be estimated using
the negative predictive value of the overall assessment of a complete response
including PET-FDG but also the clinical evaluation and imaging.
- The evaluation of the ability of PET-FDG to correctly predict remaining pathologically
invaded lymph nodes (PPV) after chemoradiotherapy for advanced HNSCC in patients
with a postchemoradiation positive PET a (and who will therefore be considered with
less than a complete regional or locoregional response and who will undergo at least
neck dissection.
Inclusion Criteria:
- Biopsy-proven HNSCC
- Clinical stage: unpreviously treated T1-T4 oral cavity, oropharynx, hypopharynx,
larynx
- Only patients suitable for at least a neck dissection after chemoradiotherapy will be
included. Consequently, inclusion criteria are thus : T1-T4 , N1 N2a, N2b N2c N3
M0.
- Patient scheduled for an organ preservation treatment protocol based on concomitant
chemoradiation (induction chemotherapy is allowed if this approach is followed by
concomitant chemoradiation)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced
Outcome Time Frame:
12 weeks after chemoradiation
Safety Issue:
No
Principal Investigator
Marc Hamoir, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cliniques Universitaires Saint-Luc, Brussels
Authority:
Belgium: Institutional Review Board
Study ID:
PET N GETTEC
NCT ID:
NCT00634777
Start Date:
January 2007
Completion Date:
January 2012
Related Keywords:
- Head and Neck Squamous Cell Carcinoma
- HNSCC biopsy-proven
- T1-T4 oral cavity oropharynx hypopharynx larynx
- N+ scheduled for an organ preservation treatment protocol based on concomitant
- chemoradiation
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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