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

Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208883
• Other study ID #: 2010/510
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2010
• Last updated: January 23, 2014
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma

Intervention

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

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	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	No

External Links

•   website University Hospital Ghent, Belgium