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Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma (pet)
This study is currently recruiting participants.
Verified by Cliniques universitaires Saint-Luc- Université Catholique de Louvain, March 2008
First Received: March 6, 2008   Last Updated: March 12, 2008   History of Changes
Sponsors and Collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Institut Jules Bordet
University Hospital of Liege
Rennes University Hospital
Nantes University Hospital
Institut Gustave Roussy
University Hospital, Paris
Poitiers University Hospital
University Hospital, Toulouse
University Hospital, Rouen
University Hospital, Montpellier
Central Hospital, Nancy, France
Centre Oscar Lambret
Information provided by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00634777
  Purpose

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.


Condition Intervention
Head and Neck Squamous Cell Carcinoma
Other: pet scan

Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment
Official Title: Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced [ Time Frame: 12 weeks after chemoradiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 239
Study Start Date: January 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: pet scan
    pet scan
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634777

Contacts
Contact: Marc Hamoir, MD +3227641974 hamoir@orlo.ucl.ac.be
Contact: Sandra Schmitz, MD +32427641976 sandra.schmitz@clin.ucl.ac.be

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Liza Nguyen Gia, MSc     +3227644212     liza.nguyen-gia@clin.ucl.ac.be    
Contact: Sandra Schmitz, MD     +3227641476     sandra.schmitz@cllin.ucl.ac.be    
Principal Investigator: Marc Hamoir, MD            
Sub-Investigator: Max Lonneux, MD            
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Institut Jules Bordet
University Hospital of Liege
Rennes University Hospital
Nantes University Hospital
Institut Gustave Roussy
University Hospital, Paris
Poitiers University Hospital
University Hospital, Toulouse
University Hospital, Rouen
University Hospital, Montpellier
Central Hospital, Nancy, France
Centre Oscar Lambret
Investigators
Study Chair: Marc Hamoir, MD Cliniques Universitaires Saint-Luc, Brussels
Principal Investigator: Guy Andry, MD Institut Jules Bordet, Brussels
  More Information

No publications provided

Responsible Party: Cliniques Universitaires Saint-Luc ( Prof Hamoir )
Study ID Numbers: PET N GETTEC
Study First Received: March 6, 2008
Last Updated: March 12, 2008
ClinicalTrials.gov Identifier: NCT00634777     History of Changes
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
HNSCC biopsy-proven
unpreviously treated
T1-T4 oral cavity oropharynx hypopharynx larynx
N1 N2a N2b N2c N3 M0
scheduled for an organ preservation treatment protocol based on concomitant
chemoradiation

Study placed in the following topic categories:
Epidermoid Carcinoma
Carcinoma, Squamous Cell of Head and Neck
Neoplasms, Squamous Cell
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009