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NCT03096808 Clinical Trial

Adaptive Radiotherapy for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03096808
Other study ID # 17-148
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 15, 2017
Est. completion date October 22, 2021

Study information
Verified date October 2021
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date October 22, 2021
Est. primary completion date October 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Adaptive 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.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge 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 Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
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

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with locoregional recurrence-free interval 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. 2 years
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