Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Cell Carcinoma Clinical Trial

— pet  

Official title:

Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00634777
• Other study ID #: PET N GETTEC
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2008
• Last updated: July 19, 2011
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: July 2011
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Marc Hamoir, MD
• Phone: +3227641974
• Email: marc.hamoir[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patients with advanced head and neck squamous cell carcinoma (HNSCC) may benefit from organ-preservation treatment based on combination of chemotherapy and radiotherapy without compromising disease-free and overall survival. In patients with initially advanced regional disease, there is controversy about the place of routine planned lymph node neck dissection after chemoradiotherapy, especially in responding patients without clinically invaded residual lymph nodes. There is uncertainty about the lymph nodes status after chemoradiation because the structural imaging modalities (CT, MRI) lack sensitivity and specificity : small positive lymph nodes are not detected, and residual large lymph nodes can be sterilized ( " ghosts nodes " with no sign of viable tumor cells at histopathology). Despite the absence of evidence based on prospective study, in numerous institutions currently, head and neck surgeons are quite reluctant to operate on for neck dissection patients with a complete clinical and radiological response following chemoradiation.

Metabolic imaging of tumors using PET and the glucose analog FDG has proven effective in head and neck SCC, especially after treatment to differentiate disease progression from radiation-induced inflammation.1 Several studies have shown that the metabolic response could predict the presence or absence of residual tumor cells in the primary tumor as well as the probability of relapse .2-4 Conflicting results have been reported on the use of PET to predict the pathological nodal status after chemoradiation, with negative predictive values ranging from 14 % to 100 %.5,6 Discrepancies observed might be due to the fact that PET was performed at variable time points after the end of radiotherapy. Ideally, PET should be performed as late as possible so that tumor regrowth can begin and become detectable, increasing the sensitivity of the procedure.

Description:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 239
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Other:
• pet scan
pet scan

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (13)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Central Hospital, Nancy, France, Centre Oscar Lambret, Gustave Roussy, Cancer Campus, Grand Paris, Jules Bordet Institute, Nantes University Hospital, Poitiers University Hospital, Rennes University Hospital, University Hospital of Liege, University Hospital, Montpellier, University Hospital, Paris, University Hospital, Rouen, University Hospital, Toulouse

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced		12 weeks after chemoradiation	No