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NCT00528294 Clinical Trial

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

Head and Neck Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00528294
Other study ID # 2007/010
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date February 2007
Est. completion date September 2015

Study information
Verified date December 2014
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Recurrent or new head or neck tumor - 18 years or older

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• GRID radiotherapy
GRID-radiotherapy followed by biological imaging guided IMRT

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose. 3 months after end of treatment
Primary Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose. 1 year.
See also
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Recruiting NCT05671458 - Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors N/A
Recruiting NCT04671485 - Effectiveness of autoHYpnosis in the Prevention of Anxiety During Radiotherapy of Head and Neck Tumors (HYMACO) N/A
Completed NCT02855723 - Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Tumor Stage 1 or 2, Nodes 0 (T1-T2 N0) Operable N/A

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