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NCT04892303 · ClinicalTrials.gov registry record · Phase 1
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
A Phase 1 study of Recurrent Thyroid Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04892303: Recruiting Phase 1 study of Recurrent Thyroid Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04892303 is a Phase 1 study of Recurrent Thyroid Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04892303, a Phase 1 study of Recurrent Thyroid Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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)
Conditions Studied
Interventions
- COMBINATION_PRODUCT Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI)
Study Locations (1)
Maryland
- The Johns Hopkins SKCCC - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
What NCT04892303 shows while recruiting
NCT04892303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Recurrent Thyroid Cancer appearing as the primary indexed condition, and to 1 intervention - of which Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI) is the first listed.
NCT04892303 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04892303 about?
NCT04892303 is a clinical study titled "Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer". 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 ...
What is the current status of trial NCT04892303?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2021-03-17. Estimated completion is 2030-12.
What conditions does trial NCT04892303 study?
This clinical trial studies the following conditions: Recurrent Thyroid Cancer.
What interventions are being tested in trial NCT04892303?
The interventions under investigation include: Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04892303?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04892303 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04892303's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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