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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04278118
Status
Recruiting
Apply to this trial

Conditions

  • Grade I Meningioma
  • Grade II Meningioma
  • Grade III Meningioma
  • Intracranial Neoplasm
  • Nerve Sheath Neoplasm
  • Pituitary Gland Adenoma
  • Schwannoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated proton or photon radiation therapy
  • Photon Beam Radiation Therapy — RADIATION
    Undergo hypofractionated proton or photon radiation therapy
  • Proton Beam Radiation Therapy — RADIATION
    Undergo hypofractionated proton or photon radiation therapy
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Feb 18, 2020
Status verified
Jan 2026
Primary completion
Dec 1, 2030
Completion
Dec 1, 2031

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (hypofractionated radiation therapy)
    Patients with benign and radiographically diagnosed intracranial tumors undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 17 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort II (hypofractionated radiation therapy)
    Patients with pathologically confirmed World Health Organization (WHO) grade 2-3 meningiomas undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 20 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

local tumor control [ Time Frame: Up to 3 years since enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Bree R. Eaton
[email protected]
404-251-2690
Bree R. Eaton (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

Related Studies