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

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ClinicalTrials.gov Identifier: NCT00634777
Recruitment Status : Unknown
Verified July 2011 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : March 13, 2008
Last Update Posted : July 20, 2011
Sponsor:
Collaborators:
Jules Bordet Institute
University Hospital of Liege
Rennes University Hospital
Nantes University Hospital
Gustave Roussy, Cancer Campus, Grand Paris
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

Brief 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.


Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Other: pet scan Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 239 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma
Study Start Date : January 2007
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: pet scan
    pet scan


Primary Outcome Measures :
  1. Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced [ Time Frame: 12 weeks after chemoradiation ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634777


Contacts
Contact: Marc Hamoir, MD +3227641974 marc.hamoir@uclouvain.be
Contact: Sandra Schmitz, MD +32427641976 schmitz_sany@hotmail.com

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Liza Nguyen Gia, MSc    +3227641274    liza.nguyen-gia@uclouvain.be   
Contact: Sandra Schmitz, MD    +3227641976    schmitz_sany@hotmail.com   
Principal Investigator: Marc Hamoir, MD         
Sub-Investigator: Max Lonneux, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Jules Bordet Institute
University Hospital of Liege
Rennes University Hospital
Nantes University Hospital
Gustave Roussy, Cancer Campus, Grand Paris
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

Responsible Party: Prof Hamoir, Cliniques Universitaires Saint-Luc
ClinicalTrials.gov Identifier: NCT00634777     History of Changes
Other Study ID Numbers: PET N GETTEC
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
HNSCC biopsy-proven
T1-T4 oral cavity oropharynx hypopharynx larynx
N+ scheduled for an organ preservation treatment protocol based on concomitant
chemoradiation

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