Double radiation attack aims to blast stubborn thyroid cancer
NCT ID NCT04892303
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study tests a new way to treat thyroid cancer that has returned or spread. It combines two types of radiation—external beam radiation and radioactive iodine—to deliver a stronger dose to tumors. The goal is to see if this combination is safe and can give a higher radiation dose than either treatment alone. The trial includes adults with a specific type of thyroid cancer that still takes up iodine and cannot be fully removed by surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- external beam radiation plus radioactive iodine (131-I)
- What this could lead to
- If successful, this approach could allow higher radiation doses to thyroid cancer tumors, potentially improving tumor control without increasing side effects.
- What could go wrong
- This is an early-phase safety trial with only 48 participants, so effectiveness is not yet proven. There is a risk of serious side effects from the combined radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion: * 18 and 85 years, inclusive. * Histologically confirmed papillary or follicular thyroid carcinoma, collectively referred to as differentiated thyroid carcinoma (DTC), that is incompletely responsive to initial surgery +/- 131-Iodine as established by anatomic imaging (CT, MRI, and Ultrasound). * DTC that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases. * Iodine avid residual disease, but with a sub-therapeutic level of lesional radioiodine uptake demonstrated in either a pre-treatment diagnostic scan or a previous post-treatment radioiodine scan, making it unlikely that the patient would benefit from radioiodine therapy alone. * Adequate organ function, including: a) adequate renal function, defined as a measured creatinine clearance \>70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR); and b) adequate hematologic function, defined as a platelet count \> 50,000 cells/mm3 and an absolute neutrophil count (ANC) \> 500 cells/mm3 * Life expectancy of at least 8 weeks. * Karnofsky performance status (KPS) \> 50% * Patients must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to CTCAE v5.0 grade 2 or better. * Patients with previously identified cardiac disease will be eligible, as Sodium Iodide I-131 (131I NaI) is not expected to cause cardiac dysfunction Exclusion: * Patient is pregnant or breastfeeding. * Patient is sexually active, premenopausal, and does not agree to use accepted, effective forms of contraception. * Any criteria that would contraindicate radioiodine therapy or external beam radiotherapy. * Patient having alimentary toxic aleukia (ATA) low and intermediate risk tumors, not meeting the guidelines for either radioactive iodine (RAI) treatment or External beam radiotherapy (EBRT). * Patient with advanced central nervous system (CNS) metastatic disease, critical lesions in the hip and spine, etc. that would make RAI treatment prior to EBRT potentially harmful, with respect to worsening of disease as a result of the recombinant thyroid-stimulating hormone (TSH) stimulation. * Patients having recent exposure to iodinated contrast (within 6 weeks, that could render RAI treatment ineffective).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Johns Hopkins SKCCC
RECRUITINGBaltimore, Maryland, 21287, United States
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