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NCT04278118 · ClinicalTrials.gov registry record · NA
Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study
A NA study of Schwannoma and Grade III Meningioma, sponsored by Emory University.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT04278118: Recruiting NA study of Schwannoma and Grade III Meningioma, sponsored by Emory University.
NCT04278118 is a NA study of Schwannoma and Grade III Meningioma that is actively recruiting participants, run by Emory University. The registered enrollment target is 70 participants, below the 106-participant average among 3 other Schwannoma trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04278118, a NA study of Schwannoma and Grade III Meningioma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well hypofractionated proton or photon radiation therapy works in treating patients with brain tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells. A shorter duration of radiation treatment may avoid some of the delayed side effects of radiation while providing a more convenient treatment and reducing costs.
Primary Outcome
Will assess local tumor control rate. Local tumor control is defined as freedom from progressive disease (PD). Will be calculated as the proportion of patients who did not experience PD within 3-year follow up with 95% binomial proportion confidence interval for the entire population and each cohort independently. The same calculation will be repeated for the entire study population and each cohort separately. Kaplan-Meier method will be used to estimate the local control rates for the entire po
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Hypofractionated Radiation Therapy
- RADIATION Photon Beam Radiation Therapy
- RADIATION Proton Beam Radiation Therapy
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2031-12-01 |
| Phase | NA |
What NCT04278118 shows while recruiting
NCT04278118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 106-participant average among 3 other Schwannoma trials with a reported enrollment target (34% lower).
The record links to 7 conditions, with Schwannoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04278118 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04278118 about?
NCT04278118 is a clinical study titled "Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study". This phase II trial studies how well hypofractionated proton or photon radiation therapy works in treating patients with brain tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells. A shorter duration of radi...
What is the current status of trial NCT04278118?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2020-02-18. Estimated completion is 2031-12-01.
What conditions does trial NCT04278118 study?
This clinical trial studies the following conditions: Schwannoma, Grade III Meningioma, Grade II Meningioma, Intracranial Neoplasm, Grade I Meningioma.
What interventions are being tested in trial NCT04278118?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Hypofractionated Radiation Therapy (RADIATION), Photon Beam Radiation Therapy (RADIATION), Proton Beam Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04278118?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04278118 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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