What side effects are associated with this type of intervention?

The most common treatments for thyroid cancer, such as Radioactive Iodine (RAI, 131-I) and External Beam Radiotherapy (XRT), have distinct side effects. RAI can cause dry mouth, altered taste, nausea, and an increased risk of secondary malignancies like leukemia. XRT may lead to skin irritation, fatigue, difficulty swallowing, and potential damage to surrounding tissues. When combined, these treatments may amplify these side effects and increase the risk of more severe tissue damage and secondary cancers due to higher cumulative radiation exposure.

What prior FDA approvals exist?

The FDA has approved several treatments for thyroid cancer that align with the methods of Radioactive Iodine (RAI, 131-I) and External Beam Radiotherapy (XRT). Radioactive Iodine (RAI) therapy, which involves the use of iodine-131 to deliver internal radiation to thyroid cancer cells, has been a standard treatment for differentiated thyroid cancer. External Beam Radiotherapy (XRT) is also used, particularly for cases where the cancer is locally advanced or not fully resectable. While specific FDA approvals for the combined use of RAI and XRT are not detailed, these therapies are commonly used in clinical practice to manage thyroid cancer, especially in cases with iodine-avid metastases or locally invasive disease.

What other types of research exist?

One promising alternative to combined RAI and XRT for thyroid cancer patients is the use of Intensity-Modulated Radiotherapy (IMRT) combined with iodine-125 seed implantation. This approach allows for precise targeting of the tumor with high radiation doses while sparing surrounding healthy tissue. Additionally, the use of systemic therapies such as targeted therapies (e.g., tyrosine kinase inhibitors) and immunotherapies are emerging as potential treatments for thyroid cancer, offering new avenues for patients who may not respond well to traditional radiotherapy methods.

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Radiotherapy + Radiopharmaceutical Therapy for Thyroid Cancer

Phase 1

Recruiting

Led By Harry Quon, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status (KPS) > 50%

DTC that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases

Must not have

Any criteria that would contraindicate radioiodine therapy or external beam radiotherapy

Patients with alimentary toxic aleukia (ATA) low and intermediate risk tumors not meeting the guidelines for either radioactive iodine (RAI) treatment or External beam radiotherapy (EBRT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of radioactive iodine and targeted radiation therapy for thyroid cancer that has spread and cannot be fully removed by surgery. The goal is to deliver higher doses of radiation directly to the cancer cells, making the treatment more effective. Radioactive iodine therapy has been used for several decades to treat thyroid cancer by leveraging the ability of thyroid cells to uptake iodine.

Who is the study for?

This trial is for adults aged 18-85 with well-differentiated thyroid cancer that's spread and can't be fully removed by surgery. They should have a life expectancy of at least 8 weeks, adequate organ function, and a Karnofsky performance status over 50%. Pregnant or breastfeeding individuals, those recently exposed to iodinated contrast, or sexually active premenopausal patients not using contraception are excluded.

What is being tested?

The study tests combining external beam radiation (XRT) with radioactive iodine (RAI) treatment in patients with metastatic thyroid cancer. The aim is to safely deliver higher tumor radiation doses through precise dosimetric planning. Researchers will monitor safety based on severe toxicity incidence during and after treatment.

What are the potential side effects?

Potential side effects include damage to nearby organs due to radiation exposure, changes in blood counts leading to increased infection risk or bleeding problems, kidney issues from the radiopharmaceutical agent used, fatigue from therapy, and possible acute reactions during infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but cannot do normal activities or work.

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My thyroid cancer has spread to my neck and/or other parts of my body and cannot be fully removed by surgery.

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My thyroid cancer didn't fully respond to surgery or iodine treatment.

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My cancer absorbs iodine but hasn't responded well to radioiodine treatment.

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I have a known heart condition.

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I am between 18 and 85 years old.

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My kidney and blood cell counts are within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no health issues that prevent me from receiving radioiodine or external beam radiotherapy.

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My tumor is low or intermediate risk and doesn't qualify for specific radiation treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Tumor Response (1)

Tumor Response (2)

Tumor Response (3)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: High-risk thyroid cancer patientsExperimental Treatment1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radioactive Iodine (RAI, 131-I) therapy works by taking advantage of the thyroid gland's natural ability to absorb iodine. When administered, the radioactive iodine is selectively taken up by thyroid cancer cells, delivering targeted internal radiation that destroys these cells with minimal impact on surrounding tissues. External Beam Radiotherapy (XRT) involves directing high-energy radiation beams from outside the body to the tumor site, which helps to control or reduce the size of the tumor by damaging the DNA of cancer cells, thereby inhibiting their ability to grow and divide. Combining RAI and XRT can optimize the radiation dose delivered to thyroid cancer cells, potentially increasing treatment efficacy while maintaining safety. This combined approach is particularly important for patients with metastatic or non-resectable thyroid cancer, as it may offer improved outcomes compared to either treatment alone.