Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
1 other identifier
interventional
27
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2013
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2013
CompletedStudy Start
First participant enrolled
June 13, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2021
CompletedResults Posted
Study results publicly available
December 29, 2022
CompletedDecember 29, 2022
November 1, 2021
8.4 years
June 13, 2013
October 13, 2022
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Overall Survival
2 years
Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities
2 years
Rate of Late Dysphagia
2 years
Rate of Late Xerostomia/Dry Mouth
2 years
Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline
12 months
Study Arms (1)
IMRT and doxorubicin
EXPERIMENTALAll patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
Interventions
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
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.
Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.
The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who are pregnant or lactating
- Inability to comply with study and/or follow-up procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
Related Publications (1)
Romesser PB, Sherman EJ, Whiting K, Ho ML, Shaha AR, Sabra MM, Riaz N, Waldenberg TE, Sabol CR, Ganly I, McBride SM, Fagin JA, Zhang Z, Tuttle RM, Wong RJ, Lee NY. Intensity-modulated radiation therapy and doxorubicin in thyroid cancer: A prospective phase 2 trial. Cancer. 2021 Nov 15;127(22):4161-4170. doi: 10.1002/cncr.33804. Epub 2021 Jul 22.
PMID: 34293201DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nancy Lee, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Lee, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2013
First Posted
June 20, 2013
Study Start
June 13, 2013
Primary Completion
November 4, 2021
Study Completion
November 4, 2021
Last Updated
December 29, 2022
Results First Posted
December 29, 2022
Record last verified: 2021-11