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

Phase 1

Terminated

• Conditions: Head and Neck Tumors
• Interventions: Radiation: GRID radiotherapy

• Registration Number: NCT00528294
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Status Verified: 2014-12
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Recurrent or new head or neck tumor
• 18 years or older

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	GRID radiotherapy	GRID-radiotherapy followed by biological imaging guided IMRT

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium