NCT00634777

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

5 years

First QC Date

March 6, 2008

Last Update Submit

July 19, 2011

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC biopsy-provenT1-T4 oral cavity oropharynx hypopharynx larynxN+ scheduled for an organ preservation treatment protocol based on concomitantchemoradiation

Outcome Measures

Primary Outcomes (1)

  • Efficacy of PET scan in evaluation of patient with HNSCC regionally advanced

    12 weeks after chemoradiation

Interventions

pet scanOTHER

pet scan

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-proven HNSCC
  • Clinical stage: unpreviously treated T1-T4 oral cavity, oropharynx, hypopharynx, larynx
  • Patient scheduled for an organ preservation treatment protocol based on concomitant chemoradiation (induction chemotherapy is allowed if this approach is followed by concomitant chemoradiation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Marc Hamoir, MD

    Cliniques Universitaires Saint-Luc, Brussels

    STUDY CHAIR

  • Guy Andry, MD

    Institut Jules Bordet, Brussels

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Hamoir, MD

CONTACT

+3227641974marc.hamoir@uclouvain.be

Sandra Schmitz, MD

CONTACT

+32427641976schmitz_sany@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2008

First Posted

March 13, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

BE(1)