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NOT YET RECRUITING
NCT07869524
PHASE3

IMPT Versus IMRT for Diffuse Intrinsic Pontine Glioma

Sponsor: Shandong Cancer Hospital and Institute

View on ClinicalTrials.gov

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

Interventions

RADIATION

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.

RADIATION

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