Adaptive Radiotherapy for Head and Neck Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer, Oral Cavity Cancer, Nasopharynx Cancer, Larynx Cancer, Hypopharynx Cancer

Intervention / Treatment
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* Radiation: Adaptive Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptive Radiotherapy<br>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. | Radiation: Adaptive Radiotherapy<br>* 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.<br>* Other names: ART;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adaptive radiotherapy, ART, intensity modulated radiation therapy, IMRT