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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Thyroid Cancer

Treatments: Drug: Doxorubicin; Radiation: IMRT; Device: DWI MRI; Other: Modified Barium Swallow Impairment Profile (MBSImP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01882816

13-070

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

IMRT and doxorubicin

Experimental group

Description:

All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.

Treatment:

Device: DWI MRI

Other: Modified Barium Swallow Impairment Profile (MBSImP)

Radiation: IMRT

Drug: Doxorubicin