Status:
RECRUITING
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Thyroid Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
The goal of this study is to evaluate combined radioactive iodine (RAI, 131-I) and external beam radiotherapy (XRT) to optimize the radiation dose delivered to treat well differentiated thyroid cancer...
Detailed Description
The study goal is to evaluate combined radioactive iodine (RAI, 131-I) and external beam radiotherapy (XRT) to optimize the radiation dose delivered to treat well-differentiated thyroid cancers (DTC) ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04892303
Start Date
March 17 2021
End Date
December 1 2030
Last Update
July 1 2025
Active Locations (1)
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1
The Johns Hopkins SKCCC
Baltimore, Maryland, United States, 21287