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NCT03184038 · ClinicalTrials.gov registry record · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
A NA study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT03184038: Recruiting NA study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03184038 is a NA study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 90 participants, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (56% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03184038, a NA study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.
Primary Outcome
The proportion of patients with neurocognitive decline at 4 months post stereotactic radiosurgery (SRS) treatment in each group will be estimated using the sample proportion with the corresponding two-sided 95% confidence interval. The determination of neurocognitive decline will be based on a battery of tests: Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A a
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- RADIATION Stereotactic Body Radiation Therapy
- RADIATION Stereotactic Radiosurgery
- PROCEDURE Cognitive Assessment
Study Locations (2)
New Jersey
- Jefferson Health New Jersey - Sewell
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
What NCT03184038 shows while recruiting
NCT03184038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03184038 reports a single indexed study location in New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03184038 about?
NCT03184038 is a clinical study titled "Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery". This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors ...
What is the current status of trial NCT03184038?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2017-02-21. Estimated completion is 2026-09-30.
What conditions does trial NCT03184038 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain.
What interventions are being tested in trial NCT03184038?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Stereotactic Body Radiation Therapy (RADIATION), Stereotactic Radiosurgery (RADIATION), Cognitive Assessment (PROCEDURE).
Who is sponsoring clinical trial NCT03184038?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03184038 being conducted?
This trial has 2 study locations across New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03184038's enrollment target sits among peer trials
90 31st of 92 higher than 62 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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.
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