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

Phase 2

Completed

• Conditions: Thyroid Cancer
• Interventions: Radiation: IMRT; Device: DWI MRI; Drug: Doxorubicin; Other: Modified Barium Swallow Impairment Profile (MBSImP)

• Registration Number: NCT01882816
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-13
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-20
• Status Verified: 2021-11
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Results First Submitted: 2022-10-13
• Results First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Results First Posted: 2022-12-29
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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Exclusion Criteria

• Women who are pregnant or lactating
• Inability to comply with study and/or follow-up procedures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT and doxorubicin	IMRT	All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
IMRT and doxorubicin	DWI MRI	All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
IMRT and doxorubicin	Modified Barium Swallow Impairment Profile (MBSImP)	All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
IMRT and doxorubicin	Doxorubicin	All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Local-regional Progression-free Survival	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years
Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline	12 months	Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study
Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities	2 years	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.
Rate of Late Dysphagia	2 years	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
Rate of Late Xerostomia/Dry Mouth	2 years	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

Trial Locations

Locations (6)

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, 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 Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Rockville Centre; 🇺🇸 Rockville Centre, New York, United States