Actively Recruiting
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-07-01
48
Participants Needed
1
Research Sites
506 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 cancers (DTC) with iodine-avid metastases. The investigators hypothesize that precise dosimetric planning will permit this combined RAI-XRT radiotherapeutic approach to be safe and permit higher tumor radiation doses than could otherwise be delivered. Patients with metastatic well-differentiated DTC) that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases, are the target study population. The primary objective is to evaluate safety as defined by the incidence of maximum grade 3 or greater NCI CTCAE toxicity observed during the treatment period and for the first 30 days following completion of radiotherapy. Secondary endpoints will evaluate efficacy at 6 months and feasibility of this combination to deliver a minimum cumulative dose of 80 Gy to the index tumors selected prior to treatment initiation. The investigators plan to enroll 48 subjects at an accrual rate of 1 subject per month over a study duration of 4 years.
CONDITIONS
Official Title
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 85 years, inclusive
- Histologically confirmed papillary or follicular thyroid carcinoma (differentiated thyroid carcinoma) not fully responsive to initial surgery and/or radioactive iodine treatment
- Thyroid cancer not completely removable with tumor invasion into cervical soft tissues or non-removable distant metastases
- Iodine-avid residual disease with sub-therapeutic radioiodine uptake shown in diagnostic or post-treatment scans
- Adequate kidney function, with creatinine clearance over 70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate
- Adequate blood counts, with platelet count over 50,000 cells/mm3 and absolute neutrophil count over 500 cells/mm3
- Life expectancy of at least 8 weeks
- Karnofsky performance status greater than 50%
- Fully recovered from effects of any prior chemotherapy, with toxicities improved to grade 2 or better
- Patients with prior cardiac disease are eligible as radioactive iodine is not expected to cause heart problems
You will not qualify if you...
- Pregnant or breastfeeding patients
- Sexually active, premenopausal patients not willing to use effective contraception
- Any condition that contraindicates radioiodine therapy or external beam radiotherapy
- Patients with alimentary toxic aleukia (ATA) low or intermediate risk tumors not meeting guidelines for RAI or EBRT
- Advanced central nervous system metastatic disease or critical hip/spine lesions making RAI before EBRT potentially harmful
- Recent exposure to iodinated contrast within 6 weeks, which could reduce effectiveness of RAI treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Johns Hopkins SKCCC
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
D
Dana B. Kaplin, MPH
CONTACT
H
Harry Quon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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