Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer

Study Overview
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Brief Summary
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The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.

Official Title
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A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Radiation: IMRT
* Device: DWI MRI
* Drug: Doxorubicin
* Other: Modified Barium Swallow Impairment Profile (MBSImP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease. Age ≥18 years Karnofsky performance status ≥70% Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment. Patients must have ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Women who are pregnant or lactating Inability to comply with study and/or follow-up procedures

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: IMRT and doxorubicin<br>All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. | Radiation: IMRT<br>* Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC<br>Device: DWI MRI<br>* The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.<br>Drug: Doxorubicin<br>* Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.<br>Other: Modified Barium Swallow Impairment Profile (MBSImP)<br>* The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Local-regional Progression-free Survival | 2-year cumulative incidence of locoregional progression/failure with death as a competing risk will be defined as infield progression if included in the RT field and meets one of the following criteria: 25% increase in tumor volume, new lesions, and/or 25% increase in metabolic tumor volume or total lesion glycolysis. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2 years | 
| Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 Physician-reported acute grade 3 or higher treatment-related toxicities, regardless of attribution. | 2 years | 
| Rate of Late Dysphagia | Grade 2 or higher late toxicity rate. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 | 2 years | 
| Rate of Late Xerostomia/Dry Mouth | Rate of late xerostomia/dry mouth. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 | 2 years | 
| Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-anaplastic, non-medullary, radiation, IMRT, Doxorubicin, 13-070