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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
Adequate recovery from the effects of any prior chemotherapy, with toxicities recovered to CTCAE v5.0 grade 2 or better
Karnofsky performance status (KPS) > 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a new way to treat thyroid cancer by combining two types of radiation. The goal is to see if it's safe and effective, and if it can deliver a high enough dose of radiation to the tumor.

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.Check my eligibility
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.See study design
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 have recovered from my last chemotherapy with mild or no side effects.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of combined therapy of XRT plus RAI measured by NCI-CTCAE toxicity
Secondary outcome measures
Tumor Response (1)
Tumor Response (2)
Tumor Response (3)

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.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,815 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,275 Total Patients Enrolled
Harry Quon, MDPrincipal InvestigatorJohns Hopkins, School of Medicine, Radiation Oncology
2 Previous Clinical Trials
3 Total Patients Enrolled

Media Library

External Beam Radiotherapy (XRT) Clinical Trial Eligibility Overview. Trial Name: NCT04892303 — Phase 1
Thyroid Cancer Research Study Groups: High-risk thyroid cancer patients
Thyroid Cancer Clinical Trial 2023: External Beam Radiotherapy (XRT) Highlights & Side Effects. Trial Name: NCT04892303 — Phase 1
External Beam Radiotherapy (XRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04892303 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications being accepted currently for this medical experiment?

"This medical study is actively recruiting, as indicated on clinicaltrials.gov. It was initially posted back in March 2021 and the information has been updated most recently at the end of October this year."

Answered by AI

What other research trials have been conducted on this therapeutic approach?

"Presently, 19 clinical trials concerning this particular treatment are in progress. Of these studies, 4 have reached the third phase of research. Most of the sites conducting this trial can be found in Sevilla and Vizcaya; altogether, 66 different locations are participating."

Answered by AI

To what extent has recruitment been successful for this medical experiment?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial is currently in search of participants. It was initially shared on March 17th 2021 and has been updated as recently as October 25th 2022, with a requirement for 48 patients from one site."

Answered by AI

What are the eligibility criteria for participation in this study?

"This clinical trial seeks 48 individuals aged 18 or older and not exceeding 85 years of age with a thyroid disorder. In order to be eligible, applicants must satisfy the following conditions: diagnoseable cancer that is not completely removable via surgery yet has infiltrated cervical soft tissues, non-recruitable distant metastases., currently pregnant or breastfeeding, life expectancy 8 weeks minimum, recovery from effects of prior chemotherapy based on organ function as per CTCAE v5.0 grade 2 standards and no previously identified cardiac complications since 131I NaI may cause such issues."

Answered by AI

Has the Food and Drug Administration sanctioned this method of care?

"Taking into account the limited safety and efficacy data, our team's assessment assigns this treatment a score of 1."

Answered by AI

Under which circumstances is this intervention typically recommended?

"This treatment has proven to be effective in treating communicable diseases, as well as providing antiseptic protection against minor cuts, scrapes or burns and hypothyroidism."

Answered by AI

Does your research encompass elderly patients?

"Adults aged 18-85 are suitable to participate in this research. There are also 34 trials for minors and 232 further studies specifically catering to those over the age of 65."

Answered by AI
~26 spots leftby Dec 2027