A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer

A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01208883

Enrollment

Registered

2010-09-24

Start date

2010-09-30

Completion date

2012-03-31

Last updated

2014-01-24

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

Conditions

Squamous Cell Carcinoma

Keywords

Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.

Brief summary

Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment \[18F\]FDG-PET acquired during treatment in adaptive \[18F\]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.

Interventions

OTHERrepetitive per-treatment [18F]FDG-PET for treatment adaptation

repetitive per-treatment \[18F\]FDG-PET for treatment adaptation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx. * Primary unresectable tumor and/or patients refused surgery. * Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis. * Multidisciplinary decision of curative radiotherapy or radiochemotherapy. * Karnofsky performance status ≥70%. * Age ≥ 18 years old. * Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion criteria

* Treatment combined with brachytherapy. * Prior irradiation to the head and neck region. * Distant metastases. * Second primary tumors that are not under control * Pregnant or lactating women. * Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment. * Allergy to the CT-contrast agents. * Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. * Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Design outcomes

Primary

Measure	Time frame
To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.	at time of per-treatment [18F]FDG-PET/CT

Countries

Belgium

Outcome results

None listed

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