This trial is active, not recruiting.

Condition head and neck tumors
Treatment grid radiotherapy
Phase phase 1
Sponsor University Hospital, Ghent
Start date February 2007
End date September 2015
Trial size 12 participants
Trial identifier NCT00528294, 2007/010


This trials examines the feasibility of GRID-therapy combined with biologically imaging based IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the total radiation dose 2 to 3 times.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
GRID-radiotherapy followed by biological imaging guided IMRT
grid radiotherapy
GRID-radiotherapy followed by biological imaging guided IMRT

Primary Outcomes

Maximum tolerated dose.
time frame: 3 months after end of treatment
Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose.
time frame: 1 year.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Recurrent or new head or neck tumor - 18 years or older

Additional Information

Official title Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
Principal investigator Wilfried De Neve, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.