NCT04892303

Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Thyroid Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI)	To safely administer a minimum cumulative dose of external beam radiation to up 3 index tumors per patient, supplemented radiation dose delivered by radioactive iodine (RAI)

Timeline

• Start date: 2021-03-17
• Primary completion: 2027-12-01
• Completion: 2030-12-01
• First posted: 2021-05-19
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States