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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 1

Conditions

Squamous Cell Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01208883

2010/510

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.