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NCT02781792 · ClinicalTrials.gov registry record · Phase 2
Temozolomide Chronotherapy for High Grade Glioma
A Phase 2 study of Glioblastoma Multiforme and Glioma, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT02781792: Completed Phase 2 study of Glioblastoma Multiforme and Glioma, sponsored by Washington University School of Medicine.
NCT02781792 is a Phase 2 study of Glioblastoma Multiforme and Glioma that has completed, run by Washington University School of Medicine. The registered enrollment target is 42 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02781792, a Phase 2 study of Glioblastoma Multiforme and Glioma, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy. Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas. Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the investigators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.
Primary Outcome
Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time.
Conditions Studied
Interventions
- DRUG Temozolomide
- OTHER Functional Assessment of Cancer Therapy - Brain
- OTHER ActTrust Condor Instrument Watch
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-08-11 |
| Est. Completion | 2024-07-18 |
| Phase | Phase 2 |
What the finished NCT02781792 record still lists
NCT02781792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.
NCT02781792 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT02781792 about?
NCT02781792 is a clinical study titled "Temozolomide Chronotherapy for High Grade Glioma". Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and g...
What is the current status of trial NCT02781792?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2016-08-11. Estimated completion is 2024-07-18.
What conditions does trial NCT02781792 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Glioma.
What interventions are being tested in trial NCT02781792?
The interventions under investigation include: Temozolomide (DRUG), Functional Assessment of Cancer Therapy - Brain (OTHER), ActTrust Condor Instrument Watch (OTHER).
Who is sponsoring clinical trial NCT02781792?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02781792 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02781792's enrollment target sits among peer trials
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