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

Memorial Sloan Kettering Cancer Center27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thyroid Cancer

Interventions

IMRTRADIATION

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

DWI MRIDEVICE

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.

DoxorubicinDRUG

Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Overall Survival

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months

Data from ClinicalTrials.gov

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