Intracranial Neoplasm Clinical Trial
Official title:
HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
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.
PRIMARY OBJECTIVE: I. To report 3 year local tumor control of moderately hypofractionated proton or photon therapy for benign intracranial tumors. SECONDARY OBJECTIVES: I. To demonstrate feasibility of moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors. II. To report physician reported acute and late toxicity of moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. III. To report neurocognitive effects, health related quality of life, and patient reported toxicity for moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: 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. COHORT II: 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. After completion of study treatment, patients are followed up periodically. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05732896 -
Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery
|
N/A | |
| Completed |
NCT04044937 -
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
|
Phase 2 | |
| Not yet recruiting |
NCT03717766 -
Application of New Technologies in the Resection of Intracranial Tumors
|
||
| Completed |
NCT05145049 -
The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies
|
||
| Terminated |
NCT03089749 -
Characterization of Human Autoantibody Titers After Central Nervous System Insult
|
||
| Not yet recruiting |
NCT05891002 -
Accuracy of Robotically Assisted Cranial Biopsies
|
||
| Recruiting |
NCT06291662 -
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
|
N/A | |
| Completed |
NCT04302857 -
Tractography Pilot Study Leipzig
|
||
| Completed |
NCT04454268 -
Intracranial Hydatid Cyst
|
N/A | |
| Completed |
NCT03076255 -
Head and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy
|
N/A | |
| Recruiting |
NCT03714347 -
The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
|
N/A | |
| Completed |
NCT03710278 -
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
|
||
| Withdrawn |
NCT03091803 -
QSM and Regional DCE MRI Permeability Using GOCART Technique
|
||
| Completed |
NCT03539731 -
[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT05904704 -
Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors
|
N/A |