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NCT03477110 · ClinicalTrials.gov registry record · Early Phase 1
Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT03477110: Completed Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03477110 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03477110, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.
Primary Outcome
Discontinuation events are defined as the discontinuation of NovoTTF-200A device for \> 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.
Interventions
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DEVICE NovoTTF-200A Device
- PROCEDURE Tumor Treating Fields Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-05-04 |
| Est. Completion | 2024-01-26 |
| Phase | Early Phase 1 |
What the finished NCT03477110 record still lists
NCT03477110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT03477110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03477110 about?
NCT03477110 is a clinical study titled "Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma". This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the gr...
What is the current status of trial NCT03477110?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2018-05-04. Estimated completion is 2024-01-26.
What interventions are being tested in trial NCT03477110?
The interventions under investigation include: Radiation Therapy (RADIATION), Temozolomide (DRUG), NovoTTF-200A Device (DEVICE), Tumor Treating Fields Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT03477110?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03477110's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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