Phase 2 N=27 Treatment

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

Thyroid Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01882816 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Dec 2022

Primary outcome: Primary: Percentage of Participants With Local-regional Progression-free Survival — 15.2 percentage of all participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: IMRT (Radiation); DWI MRI (Device); Doxorubicin (Drug); Modified Barium Swallow Impairment Profile (MBSImP) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Local-regional Progression-free Survival	15.2	—
SECONDARY Overall Survival	77.3	—
SECONDARY Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities	33.4	—
SECONDARY Rate of Late Dysphagia	8.0	—
SECONDARY Rate of Late Xerostomia/Dry Mouth	4.0	—
SECONDARY Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline	0; 27	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01882816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.