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 radiation treatment may avoid some of the delayed side effects of radiation while providing a more convenient treatment and reducing costs.
Conditions:
🦠 Grade I Meningioma 🦠 Grade II Meningioma 🦠 Grade III Meningioma 🦠 Intracranial Neoplasm 🦠 Nerve Sheath Neoplasm 🦠 Pituitary Gland Adenoma 🦠 Schwannoma
🗓️ Study Start (Actual) 18 February 2020
🗓️ Primary Completion (Estimated) 23 October 2024
✅ Study Completion (Estimated) 23 October 2025
👥 Enrollment (Estimated) 70
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 February 2020
  • First Submitted that Met QC Criteria 18 February 2020
  • First Posted 20 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 July 2024
  • Last Update Posted 12 July 2024
  • Last Verified July 2024