Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study

Launched by EMORY UNIVERSITY · Feb 18, 2020

Keywords

ClinConnect Summary

The HiPPI Study is a clinical trial exploring a type of radiation therapy called hypofractionated proton or photon therapy for patients with certain benign brain tumors, such as meningiomas, pituitary adenomas, and schwannomas. This approach delivers higher doses of radiation in a shorter time frame, which may be more effective at killing tumor cells while reducing the risk of delayed side effects. The goal is to make the treatment more convenient for patients and potentially lower costs.

To be eligible for this trial, participants must have a diagnosed benign brain tumor and be advised to receive radiation therapy. They should also be willing to sign an informed consent form. However, pregnant women and those who might become pregnant during the study cannot participate, and previous radiation treatments that overlap with the current tumor area would also exclude someone from joining. If you join the study, you can expect to receive specialized radiation treatment and regular monitoring to assess its effectiveness and any side effects.

Gender

ALL

Eligibility 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)