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| 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 |
| MedlinePlus related topics: | Cancer Nuclear Scans |
| 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 |
| 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) |
- 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 :
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Marc Hamoir, MD | +3227641974 | hamoir@orlo.ucl.ac.be |
| Contact: Sandra Schmitz, MD | +32427641976 | sandra.schmitz@clin.ucl.ac.be |
| 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 | |||||
| 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 |
| Study Chair: | Marc Hamoir, MD | Cliniques Universitaires Saint-Luc, Brussels |
| Principal Investigator: | Guy Andry, MD | Institut Jules Bordet, Brussels |
More Information
| Responsible Party: | Cliniques Universitaires Saint-Luc ( Prof Hamoir ) |
| Study ID Numbers: | PET N GETTEC |
| First Received: | March 6, 2008 |
| Last Updated: | March 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00634777 |
| Health Authority: | Belgium: Institutional Review Board |
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