Back to resultsA Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
Primary Purpose
Squamous Cell Carcinoma
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
repetitive per-treatment [18F]FDG-PET for treatment adaptation
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
Eligibility Criteria
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.
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
repetitive per-treatment [18F]FDG-PET for treatment adaptation
Arm Description
Outcomes
Primary Outcome Measures
To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.
Secondary Outcome Measures
Full Information
NCT ID
NCT01208883
First Posted
September 23, 2010
Last Updated
January 23, 2014
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01208883
Brief Title
A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
Official Title
A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
repetitive per-treatment [18F]FDG-PET for treatment adaptation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
repetitive per-treatment [18F]FDG-PET for treatment adaptation
Intervention Description
repetitive per-treatment [18F]FDG-PET for treatment adaptation
Primary Outcome Measure Information:
Title
To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.
Time Frame
at time of per-treatment [18F]FDG-PET/CT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Neve, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent, Belgium
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A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
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