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NCT00362817 · ClinicalTrials.gov registry record · Phase 1
Carboplatin and Temozolomide (Temodar) for Recurrent and Symptomatic Residual Brain Metastases
A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00362817: Completed Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT00362817 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00362817, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radiation. Survival, causes of death, recurrence of disease in the central nervous system, toxicity, and quality of life will all be measured as secondary objective in this study.
Primary Outcome
Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a \>50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progr
Interventions
- DRUG carboplatin
- DRUG temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2004-10 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
What the finished NCT00362817 record still lists
NCT00362817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which carboplatin is the first listed.
NCT00362817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00362817 about?
NCT00362817 is a clinical study titled "Carboplatin and Temozolomide (Temodar) for Recurrent and Symptomatic Residual Brain Metastases". Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already be...
What is the current status of trial NCT00362817?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2004-10. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00362817?
The interventions under investigation include: carboplatin (DRUG), temozolomide (DRUG).
Who is sponsoring clinical trial NCT00362817?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00362817's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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