RecruitingPhase 1NCT04892303

Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

48 participants

Start Date

Mar 17, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is developing better treatment planning for patients with differentiated thyroid cancer (papillary or follicular type) that did not respond fully to initial surgery and radioactive iodine (RAI) therapy. Researchers want to combine targeted radiation (external beam radiotherapy) with radioactive iodine treatment more precisely and effectively. **You may be eligible if...** - You are between 18 and 85 years old - You have papillary or follicular thyroid cancer confirmed by biopsy that has not been cured by initial surgery and/or radioactive iodine - Your tumor still absorbs some iodine (iodine-avid) but not enough to be treated with RAI alone - You have adequate kidney and blood cell counts - Your performance status is reasonably good **You may NOT be eligible if...** - You are pregnant or breastfeeding, or sexually active and premenopausal without using contraception - You have contraindications to radioactive iodine or external beam radiation - You have advanced brain or spinal metastases that would be worsened by TSH stimulation (used to prepare for RAI) - You have had recent contrast dye exposure (within 6 weeks) that could interfere with radioactive iodine uptake Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCombination 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)


Locations(1)

The Johns Hopkins SKCCC

Baltimore, Maryland, United States

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NCT04892303


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