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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882816
• Other study ID #: 13-070
• Status: Completed
• Phase: Phase 2
• Start date: June 13, 2013
• Est. completion date: November 4, 2021

Study information

• Verified date: November 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Radiation:
• IMRT
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

Device:
• DWI MRI
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.

Drug:
• Doxorubicin
Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.

Other:
• Modified Barium Swallow Impairment Profile (MBSImP)
The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.

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	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	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	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	Overall Survival		2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Memorial Sloan Kettering Cancer Center