Clinical Research Directory
Browse clinical research sites, groups, and studies.
IMPT Versus IMRT for Diffuse Intrinsic Pontine Glioma
Sponsor: Shandong Cancer Hospital and Institute
Summary
This is a prospective, open-label, multicenter, phase III randomized controlled trial comparing intensity-modulated proton therapy (IMPT) with intensity-modulated radiation therapy (IMRT) in participants aged 3-18 years with newly diagnosed diffuse intrinsic pontine glioma (DIPG). Eligible participants will be randomly assigned in a 1:1 ratio to the IMPT group or the IMRT group. Both groups will receive concurrent and adjuvant temozolomide and standardized supportive care. The primary endpoint is the 1-year overall survival rate. Secondary endpoints include the 1-year progression-free survival rate, radiographic tumor response, treatment-related adverse events, neurological function, corticosteroid use, and quality of life. Exploratory analyses will evaluate potential tumor- and blood-based molecular and immune biomarkers. A total of 142 participants are planned to be enrolled. The study aims to compare the efficacy and safety of IMPT and IMRT in patients with newly diagnosed DIPG.
Official title: A Prospective, Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of Intensity-Modulated Proton Therapy Versus Intensity-Modulated Photon Radiation Therapy for Diffuse Intrinsic Pontine Glioma (imPro-DIPG-01)
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2026-12-01
Completion Date
2031-12-31
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Intensity-Modulated Proton Therapy (IMPT)
Intensity-modulated proton therapy (IMPT) delivered at a total dose of 54 Gy in 30 fractions (1.8-2.0 Gy per fraction) for patients with diffuse intrinsic pontine glioma.Concurrent and adjuvant temozolomide therapy will be administered according to standard treatment protocols.
Intensity-Modulated Radiation Therapy (IMRT)
Intensity-modulated photon radiation therapy (IMRT) delivered at a total dose of 54 Gy in 30 fractions (1.8-2.0 Gy per fraction) for patients with diffuse intrinsic pontine glioma. Concurrent and adjuvant temozolomide therapy will be administered according to standard treatment protocols.
Locations (1)
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China