Clinical trial · Interventional
Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study
HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
NCT04278118CI-TRIAL-00103436HiPPIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Grade III Meningioma | Grade 3 Meningioma | CURATED_BROADER | 0.80 |
| Grade II Meningioma | Grade 2 Meningioma | CURATED_BROADER | 0.80 |
| Grade I Meningioma | Grade 1 Meningioma | CURATED_BROADER | 0.80 |
| Intracranial Neoplasm | Intracranial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Nerve Sheath Neoplasm | Nerve Sheath Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pituitary Gland Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Schwannoma | Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
| Photon Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Proton Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I (hypofractionated radiation therapy)
- description
- 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.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
- Radiation: Photon Beam Radiation Therapy
- Radiation: Proton Beam Radiation Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Cohort II (hypofractionated radiation therapy)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.