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NCT01553916 · ClinicalTrials.gov registry record · Phase 1
Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01553916: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT01553916 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01553916, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This phase I/II trial studies the effects and safety of giving lithium carbonate (lithium) to patients with small cell lung cancer (SCLC) undergoing radiation therapy to the brain (PCI; prophylactic cranial irradiation). PCI is used to prevent cancer metastases from returning in the brain. This treatment can cause short-term memory problems by damaging the hippocampus. Lithium may help prevent or lessen memory problems caused by PCI by protecting the hippocampus.
Primary Outcome
-Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as \< 2 patients experiencing DLTs of the first 6 treated.
Interventions
- DRUG Lithium Carbonate
- RADIATION Prophylactic cranial irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-04-26 |
| Est. Completion | 2017-06-05 |
| Phase | Phase 1 |
What the finished NCT01553916 record still lists
NCT01553916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Lithium Carbonate is the first listed.
NCT01553916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01553916 about?
NCT01553916 is a clinical study titled "Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain". This phase I/II trial studies the effects and safety of giving lithium carbonate (lithium) to patients with small cell lung cancer (SCLC) undergoing radiation therapy to the brain (PCI; prophylactic cranial irradiation). PCI is used to prevent cancer metastases from returning in the brain. This trea...
What is the current status of trial NCT01553916?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-04-26. Estimated completion is 2017-06-05.
What interventions are being tested in trial NCT01553916?
The interventions under investigation include: Lithium Carbonate (DRUG), Prophylactic cranial irradiation (RADIATION).
Who is sponsoring clinical trial NCT01553916?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01553916's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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