Status:
COMPLETED
A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
Lead Sponsor:
University Hospital, Ghent
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 tria...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01208883
Start Date
September 1 2010
End Date
March 1 2012
Last Update
January 24 2014
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium