Hypofractionated proton therapy for benign brain tumors
HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
This study is testing a new way of giving radiation therapy to see if it can help people with benign brain tumors feel better while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04278118 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of hypofractionated proton or photon radiation therapy in treating patients with benign intracranial tumors, including various grades of meningiomas. The approach involves delivering higher doses of radiation over a shorter treatment period, which may enhance tumor cell death while minimizing delayed side effects. Patients are assigned to cohorts based on their tumor type and receive treatment daily for several weeks, followed by periodic follow-ups to assess outcomes and side effects.
Who should consider this trial
Good fit: Ideal candidates include individuals with pathologically or radiographically diagnosed benign intracranial tumors or nerve sheath tumors, particularly those with WHO grade 2-3 meningiomas.
Not a fit: Patients with malignant tumors or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and convenient option for patients with benign brain tumors, potentially improving tumor control and quality of life.
How similar studies have performed: Other studies have shown promise with hypofractionated radiation therapy approaches, suggesting potential for success in this trial as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically or radiographically diagnosed benign intracranial or nerve sheath tumor, including meningiomas, pituitary adenomas, schwannomas. World Health Organization (WHO) grade 2-3 meningiomas are also allowed * Recommended to receive proton or photon fractionated radiation therapy * Signed informed consent Exclusion Criteria: * Pregnant females are excluded. Female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy. FCBP must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. * A female of childbearing potential (FCBP) is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (if age \>= 55 years); if the female subject is \< 55 years and she has been naturally postmenopausal for \>= 1 year her reproductive status has to be verified by additional laboratory (lab) tests (\< 20 estradiol OR estradiol \< 40 with follicle stimulating hormone \[FSH\] \> 40 in women not on estrogen replacement therapy) * Prior radiation therapy that would overlap with current target volume * Inability to undergo magnetic resonance imaging (MRI)
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Bree R Eaton — Emory University Hospital/Winship Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.