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NCT00096265 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
NCT00096265: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00096265 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 126 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00096265, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor. It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases.
Primary Outcome
Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.
Interventions
- DRUG Temozolomide
- RADIATION Stereotactic Radiosurgery
- RADIATION 3-Dimensional Conformal Radiation Therapy
- DRUG Erlotinib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2004-10-06 |
| Est. Completion | 2012-04-01 |
| Phase | Phase 3 |
Why NCT00096265 stopped before completion
NCT00096265 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT00096265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00096265 about?
NCT00096265 is a clinical study titled "Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer". This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to ...
What is the current status of trial NCT00096265?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2004-10-06. Estimated completion is 2012-04-01.
What interventions are being tested in trial NCT00096265?
The interventions under investigation include: Temozolomide (DRUG), Stereotactic Radiosurgery (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION), Erlotinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00096265?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00096265's enrollment target sits among peer trials
126 1603rd of 2000 higher than 396 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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