A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 64
- Locations
- 8
- Primary Endpoint
- Number of patients with locoregional recurrence-free interval
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (IMRT) without ART.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
- •Karnofsky performance status \>= 70%
- •Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
- •Participants must have the ability to understand and the willingness to sign a written consent form
Exclusion Criteria
- •Female participants who are pregnant or breast feeding
- •Participants who are not able to comply with study and/or follow up procedures
- •Participants who have received induction chemotherapy before radiation treatment
- •Participants who had prior head and neck radiation therapy
- •Participants who are enrolled in a national/international cooperative group trials
- •Patients with metastatic disease
Outcomes
Primary Outcomes
Number of patients with locoregional recurrence-free interval
Time Frame: 2 years
This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as locoregional recurrence-free as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.