Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
- Conditions
- Recurrent Thyroid Cancer
- Interventions
- Combination Product: Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI)
- Registration Number
- NCT04892303
- 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 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.
- 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) with iodine-avid metastases, hypothesizing that this combination approach is safe and enables delivery of higher local radiation doses than could otherwise be safely delivered with either radiotherapeutic modality alone. This is an open-labeled, phase 1 clinical trial design that will enroll study subjects with recurrent DTC that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases. Study subjects will have a sub-therapeutic level of lesional RAI uptake demonstrated in either a pre-treatment diagnostic scan or a previous post-treatment radioiodine scan, making it unlikely that the patient would fully benefit from RAI therapy alone. The primary objective is evaluate safety as defined by the incidence of maximum grade 3 or greater NCI CTCAE grade toxicity observed during the treatment period and for the first 30 days following completion of radiotherapy. Additional secondary endpoints will evaluate efficacy at 6 months and feasibility of this combination to deliver a minimum cumulative dose of 80 Gy (66 Gy, Equivalent dose in 2Gy fractions (EQD2); 2 Gy per fraction) to the index tumors (up to 3 in each study subject) 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High-risk thyroid cancer patients Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI) All study patients will have histologically confirmed recurrence of thyroid cancer that is incompletely responsive to initial surgery.
- Primary Outcome Measures
Name Time Method Safety of combined therapy of XRT plus RAI measured by NCI-CTCAE toxicity Within 30 days of completing external beam radiation therapy Toxicity of combined XRT plus RAI defined by the incidence of grade 3 or greater toxicities as measured with National Cancer Institutes-Common Terminology Criteria for Adverse Events (CTCAE)
- Secondary Outcome Measures
Name Time Method Tumor Response (3) 6 months Measure tumor response by change in unstimulated serum thyroglobulin (with Thyroglobulin Antibody).
Tumor Response (2) 6 months Measure tumor response by Response evaluation criteria in solid tumors (RECIST) criteria
Tumor Response (1) 6 months Measure tumor response upon SPECT imaging
Trial Locations
- Locations (1)
The Johns Hopkins SKCCC
🇺🇸Baltimore, Maryland, United States