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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01208883
Other study ID # 2010/510
Secondary ID
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


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
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