Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Thyroid Diseases

Recurrence

Thyroid Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Radiopharmaceuticals

Iodine

Cadexomer iodine

All study patients will have histologically confirmed recurrence of thyroid cancer that is incompletely responsive to initial surgery.

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)

Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI)

Dana B. Kaplin, MPH

Harry Quon, MD

Harry Quon, M.D.

George Sgouros, PhD

Robert Hobbs, PhD

Paul Ladenson, MD

Prasanna Santhanam, MBBS

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.

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.

This is a Phase 1, prospective, open-label treatment study.

Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer

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)

Measure tumor response upon SPECT imaging

Measure tumor response by Response evaluation criteria in solid tumors (RECIST) criteria

Measure tumor response by change in unstimulated serum thyroglobulin (with Thyroglobulin Antibody).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer	NCT04892303	Recurrent Thyro...	Combination tre...	18 Years - 85 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer	NCT04892303	Recurrent Thyro...	Combination tre...	18 Years - 85 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for combination treatment (cxrpt) of external beam radiation (xrt) plus radioactive iodine (rai)