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

July 19, 2011 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marc Hamoir, MD
        • Sub-Investigator:
          • Max Lonneux, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced
Time Frame: 12 weeks after chemoradiation
12 weeks after chemoradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

University Hospital, Rouen
University Hospital, Montpellier
Central Hospital, Nancy, France
University of Liege
Poitiers University Hospital
Rennes University Hospital
University Hospital, Toulouse
Nantes University Hospital
Jules Bordet Institute
Centre Oscar Lambret
Gustave Roussy, Cancer Campus, Grand Paris
University Hospital, Paris

Investigators

  • Study Chair: Marc Hamoir, MD, Cliniques Universitaires Saint-Luc, Brussels
  • Principal Investigator: Guy Andry, MD, Institut Jules Bordet, Brussels

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET N GETTEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Squamous Cell Carcinoma

Clinical Trials on pet scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe