Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
NCT01882816 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2022-12-29
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Nancy Lee, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-13
- Primary Completion
- 2021-11-04
- Completion
- 2021-11-04
Countries
- United States
Study Locations
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