Combining radiotherapy and radioactive iodine for thyroid cancer treatment
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
This study is testing whether combining radioactive iodine and external beam radiotherapy can safely improve treatment for people with recurrent thyroid cancer that has spread and can't be fully removed.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04892303 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of combining radioactive iodine (RAI) and external beam radiotherapy (XRT) to treat recurrent well-differentiated thyroid cancers with iodine-avid metastases. The approach aims to optimize radiation doses to tumors that are not completely resectable, allowing for higher doses than either treatment could provide alone. The trial will enroll patients with specific criteria, including those with sub-therapeutic levels of RAI uptake, and will monitor toxicity and treatment outcomes over a defined period. The primary focus is on safety, with secondary endpoints assessing efficacy and feasibility of the combined treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with histologically confirmed differentiated thyroid carcinoma that is not completely resectable and has iodine-avid residual disease.
Not a fit: Patients with fully resectable thyroid cancer or those who do not have iodine-avid disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with recurrent thyroid cancer that is difficult to manage with standard therapies.
How similar studies have performed: While this approach is innovative, similar studies combining radiotherapy modalities have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Baltimore, Maryland
- The Johns Hopkins SKCCC — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Harry Quon, MD — Johns Hopkins, School of Medicine, Radiation Oncology
- Study coordinator: Dana B. Kaplin, MPH
- Email: dkaplin1@jhmi.edu
- Phone: 410-614-3950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.