Head and Neck Cancer, Hypopharynx Cancer, Larynx Cancer, Nasopharynx Cancer, Oral Cavity Cancer, Oropharynx Cancer, Paranasal Sinus Cancer
Conditions
Keywords
adaptive radiotherapy, ART, intensity modulated radiation therapy, IMRT
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.
Interventions
RADIATIONAdaptive Radiotherapy
ART involved modification of the radiation treatment plan during treatment course to account for temporal variations in anatomy due to changes in tumor volume and/or patients' weight loss.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with locoregional recurrence-free interval | 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. |
Countries
United States
Outcome results
None listed