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NCT04516070 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Radiosurgery for the Treatment of Patients With Small Cell Lung Cancer Brain Metastasis
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT04516070: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by M.D. Anderson Cancer Center.
NCT04516070 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 55 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04516070, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial investigates how stereotactic radiosurgery affects brain functions while treating patients with small cell lung cancer that has spread to the brain (brain metastasis). Standard of care treatment consists of whole brain radiation therapy, which targets the entire brain, and may result in side effects affecting the nervous system. Stereotactic radiosurgery only targets areas of the brain that are suspected to be affected by the disease. The purpose of this trial is to learn if and how patients' brain functions are affected by the use of stereotactic radiosurgery rather than whole brain radiation therapy in managing brain metastasis caused by small cell lung cancer. Stereotactic radiosurgery may help patients avoid nervous system side effects caused by whole brain radiation therapy.
Primary Outcome
Will be defined as a decline of \>= 1 standard deviation from baseline on at least 1 of the 5 cognitive tests. Will be estimated along with the 95% confidence interval. For patients with or without prior radiation therapy to the central nervous system, the cognitive decline rate will also be estimated respectively. Fisher exact test will be used to compare the neurocognitive decline rate at 3 month post-SRS in subgroups (e.g. prior therapy difference).
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- RADIATION Stereotactic Radiosurgery
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04516070 still lists
NCT04516070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (44% lower).
The record links to 5 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Questionnaire Administration is the first listed.
NCT04516070 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04516070 about?
NCT04516070 is a clinical study titled "Stereotactic Radiosurgery for the Treatment of Patients With Small Cell Lung Cancer Brain Metastasis". This phase II trial investigates how stereotactic radiosurgery affects brain functions while treating patients with small cell lung cancer that has spread to the brain (brain metastasis). Standard of care treatment consists of whole brain radiation therapy, which targets the entire brain, and may re...
What is the current status of trial NCT04516070?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2020-08-28. Estimated completion is 2026-12-31.
What conditions does trial NCT04516070 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Metastatic Lung Small Cell Carcinoma.
What interventions are being tested in trial NCT04516070?
The interventions under investigation include: Questionnaire Administration (OTHER), Stereotactic Radiosurgery (RADIATION).
Who is sponsoring clinical trial NCT04516070?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04516070 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04516070's enrollment target sits among peer trials
55 34th of 81 higher than 48 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 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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