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

NCT00634777 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2011-07-20

No results posted yet for this study

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.

Conditions

Interventions

OTHER

pet scan

pet scan

Sponsors & Collaborators

  • Jules Bordet Institute

    collaborator OTHER
  • University of Liege

    collaborator OTHER
  • Rennes University Hospital

    collaborator OTHER
  • Nantes University Hospital

    collaborator OTHER
  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER
  • University Hospital, Paris

    collaborator OTHER
  • Poitiers University Hospital

    collaborator OTHER
  • University Hospital, Toulouse

    collaborator OTHER
  • University Hospital, Rouen

    collaborator OTHER
  • University Hospital, Montpellier

    collaborator OTHER
  • Central Hospital, Nancy, France

    collaborator OTHER
  • Centre Oscar Lambret

    collaborator OTHER
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Marc Hamoir, MD · Cliniques Universitaires Saint-Luc, Brussels

  • Guy Andry, MD · Institut Jules Bordet, Brussels

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634777 on ClinicalTrials.gov