Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer

NCT04892303 | Recruiting Phase 1 DMC

• 3 other identifiers: J2066IRB00241274R01CA240779
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

• Safety of combined therapy of XRT plus RAI measured by NCI-CTCAE toxicity

  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)

  During external beam radiation therapy (over a 2 week period)

• Safety of combined therapy of XRT plus RAI measured by NCI-CTCAE toxicity

  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)

  Within 30 days of completing external beam radiation therapy

Secondary Outcomes (3)

• Tumor Response (1)

  6 months

• Tumor Response (2)

  6 months

• Tumor Response (3)

  6 months

Study Arms (1)

High-risk thyroid cancer patients

OTHER

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

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

Interventions

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

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)

Also known as: radiopharmaceutical (RPT)

High-risk thyroid cancer patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Johns Hopkins SKCCC

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Radiopharmaceuticals

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals

Study Officials

• Harry Quon, MD

  Johns Hopkins, School of Medicine, Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana B. Kaplin, MPH

CONTACT

410-614-3950; dkaplin1@jhmi.edu

Harry Quon, MD

CONTACT

410-502-3877; hquon2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 19, 2021
• Study Start: March 17, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (1)