A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01208883
First received: September 23, 2010
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Cell Carcinoma |
Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: repetitive per-treatment [18F]FDG-PET for treatment adaptation |
Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation
repetitive per-treatment [18F]FDG-PET for treatment adaptation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208883
Contacts
| Contact: Wilfried De Neve, MD, PhD | wilfried.deneve@ugent.be |
Locations
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium | |
| Principal Investigator: Wilfried De Neve, MD, PhD | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Wilfried De Neve, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01208883 History of Changes |
| Other Study ID Numbers: | 2010/510 |
| Study First Received: | September 23, 2010 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Hospital, Ghent:
|
Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx. |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 16, 2013