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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04892303
The ClinicalTrials.gov registry entry for NCT04892303 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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