Phase II Trial Evaluating Elimination of Radiation Therapy

Study Overview
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Brief Summary
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The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue

Official Title
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Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy

Conditions
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Cancer of the Larynx

Intervention / Treatment
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* Radiation: Intensity modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx . Treated with surgical resection with one (or both) side(s) of the neck pathologically N0. Indication for radiation therapy at the primary site or neck consisting of any of the below characteristics: Close margin (<= 0.5 cm) Positive margin Perineural invasion Lymphovascular space invasion Metastatic disease in more than one lymph node Metastatic disease in more than one lymph node group Extracapsular extension in any lymph node Constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion. Age >= 18. Patients must sign study specific, Institutional Review Board (IRB)-approved consent form. Exclusion Criteria: Previous head and neck cancer other than non melanoma skin cancer. Previous head and neck surgery. Female patients who are pregnant or nursing.

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: Intensity modulated radiation therapy (IMRT)<br>-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume. | Radiation: Intensity modulated radiation therapy<br> <br> * Other names: IMRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Recurrence in the Unirradiated Neck(s) | Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. Recurrence is defined as the return of cancer after treatment Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease. | 12 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan Meier Estimate of Locoregional Recurrence Free Survival | Recurrence is defined as the return of cancer after treatment Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame | 3 years | 
| Quality of Life (QOL) as Measured by Overall Global QOL Scores | -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL. | Median follow-up was 22 months | 
| Quality of Life (QOL) as Measured by Xerostomia QOL Data | -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL. | Median follow-up was 22 months | 
| Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms |  | Completion of follow-up (minimum of 5 years from completion of treatment) | 
| Disease Specific Survival Rate |  | Completion of follow-up (minimum of 5 years from completion of treatment) | 
| Kaplan Meier Estimate of Overall Survival |  | 3 years | 
| Patterns of Failure Associated With Implementation of Primary Objective | For patients who demonstrate a local failure during follow-up, a computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imagine (MRI) scan is fused with the original treatment planning CT scan using the computational environment for radiation research (CERR) developed at Washington University Medical Center. The methodology to transfer the digital imaging study via network to the radiation therapy research servers is mature. The original dose distribution and contours are correlated with the recurrent disease noted on the follow up imaging study. The recurrence is then classified as infield, marginal to the treatment field, or out of the treatment field depending on the dose received by the recurrent disease. Failures that occur in the treatment field are due to aspects of tumor biology rather than errors in the volume irradiated. As has been the case in our historical controls, the investigators expect most failures to be in the treatment field. | Completion of follow-up (minimum of 5 years from completion of treatment) |