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NCT02085304 · ClinicalTrials.gov registry record · Phase 1
Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM
A Phase 1 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02085304: Clinical Trial Phase 1 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT02085304 is a Phase 1 study that was terminated before completion, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02085304, a Phase 1 study, was terminated before completion, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to control. Recent studies show that survival improves for patients who get aggressive surgery to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment. Surgery, RT and chemo are part of regular cancer care for GBM. RT is usually done in daily doses 5 days a week over about 6 weeks. Beams of radiation are aimed at the tumor site plus some of the normal brain tissue around the tumor area. GammaKnife® (GK) radiosurgery also delivers radiation but in a larger dose over one day. GK sends beams to a precise target (tumor location) and very little normal brain tissue that is nearby. This study will compare GK treatment to the usual RT treatment after surgery, and with chemo. We want to know: * How well each treatment keeps the tumor from growing back. * What the effects (good and bad) of the treatments are. * How you rate your quality of life. * How the treatment affects your ability to think, understand, reason, and remember. * How you rate your ability to think, understand, reason, and remember. * If using a certain type of MRI scan can show the difference between new tumor growth and changes caused by treatment. * If certain features found in tumor cells can help doctors predict how tumors will respond to treatment.
Primary Outcome
health related quality of life (HRQOL) evaluations using the EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTC-QLQ C30/BCM20) and the The Functional Assessment of Cancer Therapy-Brain (FACT-Br, version 4) and cognition, (FACT-Cog, version 3) questionnaires.
Interventions
- DRUG Temozolomide
- PROCEDURE Gross total resection and Gliadel(R) wafers implanted
- RADIATION GammaKnife(R) stereotactic Radiosurgery
- RADIATION Standard fractionated radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-05-07 |
| Est. Completion | 2018-05-29 |
| Phase | Phase 1 |
Why NCT02085304 stopped before completion
NCT02085304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT02085304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02085304 about?
NCT02085304 is a clinical study titled "Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM". A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to control. Recent studies show that survival improves for patients who get aggressive surgery to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment. Surgery, RT and chemo are part...
What is the current status of trial NCT02085304?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-05-07. Estimated completion is 2018-05-29.
What interventions are being tested in trial NCT02085304?
The interventions under investigation include: Temozolomide (DRUG), Gross total resection and Gliadel(R) wafers implanted (PROCEDURE), GammaKnife(R) stereotactic Radiosurgery (RADIATION), Standard fractionated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT02085304?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02085304's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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