A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
| Registry | NCT03096808 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 64 (Actual) |
| Sponsor | Memorial Sloan Kettering Cancer Center (Other) |
| Conditions | Head and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer, Oral Cavity Cancer, Nasopharynx Cancer, Larynx Cancer, Hypopharynx Cancer |
| Interventions | Adaptive Radiotherapy (Radiation) |
| Dates | start 2017-03-15, primary completion 2021-10-22, completion 2021-10-22, first posted 2017-03-30, last updated 2021-10-26 |
| Locations | 8 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Head and Neck Cancer All trials for Paranasal Sinus Cancer All trials of Adaptive Radiotherapy
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Adaptive Radiotherapy | Experimental | Radiation: Adaptive Radiotherapy | Eligible patients will receive IMRT of 60-70Gy in 30-35 once-daily fractions with or without concurrent chemotherapy according to the current standard of care. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | Basking Ridge, New Jersey | United States | |
| Memorial Sloan Kettering Monmouth | Middletown, New Jersey | United States | |
| Memorial Sloan Kettering Bergen | Montvale, New Jersey | United States | |
| Memorial Sloan Kettering Commack | Commack, New York | United States | |
| Memoral Sloan Kettering Westchester | Harrison, New York | United States | |
| Memorial Sloan Kettering Cancer Center | New York, New York | United States | |
| Memorial Sloan Kettering Rockville Centre | Rockville Centre, New York | United States | |
| Memorial Sloan Kettering Nassau | Uniondale, New York | United States |