Phase 2
Completed N=27
Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
Source: ClinicalTrials.gov NCT01882816 ↗Enrolled (actual)
27
Serious AEs
11.1%
Results posted
Dec 2022
Primary outcomePrimary: Percentage of Participants With Local-regional Progression-free Survival — 15.2 percentage of all participants
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.
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 | — |
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
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. Informational only — not medical advice.