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Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00135161
Enrollment
40
Registered
2005-08-25
Start date
2003-09-30
Completion date
2015-08-31
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Keywords

neoplasms (squamous cell carcinoma of the head and neck region)

Brief summary

The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).

Detailed description

The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.

Interventions

PROCEDUREFDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).

Sponsors

Belgian Federation Against Cancer
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx * Patients who did not undergo surgery for the primary tumor location * Patients with a Karnofsky performance score of 70% or more * Written informed consent for participation in this trial

Exclusion criteria

* Other malignancy except for non-melanoma skin cancer * Prior irradiation to the head and neck region

Design outcomes

Primary

MeasureTime frame
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapyuntil 3 months after the end of the radiotherapy
Observation of chronic toxicityuntil 3 months after the end of the radiotherapy

Secondary

MeasureTime frame
Therapy response (2-4 months after end of radiotherapy)2-4 months after end of radiotherapy
Local control at 2 yearsat 2 years
Pattern of recurrenceat 2 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026