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NCT02709226 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02709226: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02709226 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). 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
NCT02709226, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Background: A glioblastoma is a tumor in the brain. It is treated with surgery, chemotherapy and radiation therapy. However, most people s tumors come back after therapy. When the tumor grows back, surgery or chemotherapy may not be possible or may no longer work. Repeat radiation therapy or re-irradiation, is an option for treating these tumors when they regrow. Objective: To find out the safety and highest tolerated dose of re-irradiation for people who have recurrent glioblastoma. Eligibility: People ages 18 50 who have glioblastoma that has been treated with radiation but has regrown. Design: Participants will be screened with: Medical history Physical exam MRI of the brain: They will lie in a machine that takes pictures of the brain. Participants will have baseline tests before they start therapy. These will include: Blood tests Neuropsychological tests: These test things like memory, attention, and thinking. Quality of life questionnaire Eye and hearing tests Participants will get a CT of the brain prior to radiation start in order to plan the radiation treatment. Once the plan is completed, they will receive radiation once a day Monday Friday for a total of 10 17 treatments. They will lie on their back for about 10 minutes while they get the treatment. Participants will be monitored for side effects. After they finish treatment, participants will have visits 1, 2, and 3 months later. Then they will have them every 2 months for 3 years. These will include: Medical history Physical exam Blood tests MRI of the brain. Quality of life questionnaire Neuropsychological tests (at some visits) After 3 years, participants will be contacted by phone each month.
Primary Outcome
The MTD will be based on the assessment of DLT within one month following the re-irradiation, and will be defined as the dose level at which less than one-third of patients (0/3 or 0-1/6 patients) treated at that dose experience a DLT, with the next higher dose level demonstrating a one-third or greater number of patients (\>= 2/3 or \>= 2/6 patients) having DLT.
Interventions
- RADIATION Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-06-15 |
| Est. Completion | 2023-07-19 |
| Phase | Phase 1 |
What the finished NCT02709226 record still lists
NCT02709226 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 1 intervention - of which Radiation is the first listed.
NCT02709226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02709226 about?
NCT02709226 is a clinical study titled "Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma". Background: A glioblastoma is a tumor in the brain. It is treated with surgery, chemotherapy and radiation therapy. However, most people s tumors come back after therapy. When the tumor grows back, surgery or chemotherapy may not be possible or may no longer work. Repeat radiation therapy or re-irr...
What is the current status of trial NCT02709226?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2016-06-15. Estimated completion is 2023-07-19.
What interventions are being tested in trial NCT02709226?
The interventions under investigation include: Radiation (RADIATION).
Who is sponsoring clinical trial NCT02709226?
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 NCT02709226'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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