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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

at time of per-treatment [18F]FDG-PET/CT

Safety Issue:

No

Principal Investigator

Wilfried De Neve, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Ethics Committee

Study ID:

2010/510

NCT ID:

NCT01208883

Start Date:

September 2010

Completion Date:

October 2013

Related Keywords:

  • Squamous Cell Carcinoma
  • Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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