IMPT Versus IMRT for Diffuse Intrinsic Pontine Glioma

NCT07869524 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: imPRO-DIPG-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Intrinsic Pontine Gliomas (DIPG)

Keywords

Diffuse intrinsic pontine glioma; Diffuse midline glioma; Intensity-modulated proton therapy; Intensity-modulated radiation therapy; DIPG

Outcome Measures

Primary Outcomes (1)

• 1-Year Overall Survival (OS) Rate

  1 year after randomization

Secondary Outcomes (3)

• 1-Year Progression-Free Survival (PFS) Rate

  1 year after initiation of study treatment

• Incidence of Treatment-Related Adverse Events

  From initiation of study treatment through 30 days after completion of study treatment

• Change in Pediatric Quality of Life Inventory (PedsQL) Scores

  Baseline (Day 1); weekly during the 6-week course of radiotherapy; at completion of radiotherapy (Day 42); monthly during the first year; every 3 months during years 2-3; and every 6 months after 3 years thereafter through study completion.

Study Arms (2)

Intensity-Modulated Proton Therapy (IMPT)

EXPERIMENTAL

Radiation: Intensity-Modulated Proton Therapy (IMPT)

Intensity-Modulated Radiation Therapy (IMRT)

ACTIVE COMPARATOR

Radiation: Intensity-Modulated Radiation Therapy (IMRT)

Interventions

Intensity-Modulated Proton Therapy (IMPT) RADIATION

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 Proton Therapy (IMPT)

Intensity-Modulated Radiation Therapy (IMRT) RADIATION

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.

Intensity-Modulated Radiation Therapy (IMRT)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Written informed consent must be obtained before initiation of any study-related procedures.
• Male or female participants aged ≥3 years and ≤18 years.
• Histologically confirmed grade IV diffuse midline glioma by biopsy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• No prior systemic anticancer therapy for the current locally advanced disease.
• Adequate organ function, meeting all of the following criteria:
• Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L;
• Platelet count ≥75 × 10\^9/L;
• Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN);
• Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min. For participants \<18 years of age, the Schwartz formula is recommended for estimation of creatinine clearance;
• Adequate coagulation function; isolated laboratory abnormalities may be considered acceptable if judged by the investigator to be not clinically significant;
• Cardiac enzyme profile abnormalities may be considered acceptable if judged by the investigator to be not clinically significant;
• No severe symptoms of increased intracranial pressure, such as persistent vomiting or disturbance of consciousness, or such symptoms must be stable after dehydration therapy.

You may not qualify if:

• Previous cranial radiotherapy.
• Estimated life expectancy of less than 3 months.
• Presence of other central nervous system tumors, such as metastatic tumors, or other malignancies, except for curatively resected basal cell carcinoma of the skin or papillary thyroid carcinoma.
• Current participation in another interventional clinical study.
• Contraindications to radiotherapy.
• Untreated active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with an HBV-DNA level above the upper limit of normal of the laboratory at the participating study center.
• Participants with hepatitis B may nevertheless be eligible under either of the following conditions:
• HBV viral load \<1,000 copies/mL (200 IU/mL) before the first study treatment; anti-HBV therapy should be administered throughout the study treatment period to prevent HBV reactivation;
• Participants who are anti-HBc positive, HBsAg negative, anti-HBs negative, and have an undetectable HBV viral load do not require prophylactic anti-HBV therapy but must be closely monitored for HBV reactivation.
• Active hepatitis C virus (HCV) infection, defined as HCV antibody positivity with an HCV-RNA level above the lower limit of detection.
• Any severe or uncontrolled systemic disease, including:
• (1) Clinically significant and uncontrolled abnormalities in cardiac rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation; (2) History of noninfectious pneumonitis requiring corticosteroid treatment within 1 year before the first study treatment, or current clinically active interstitial lung disease; (3) Active tuberculosis.
• Any medical history, evidence of disease, treatment, or laboratory abnormality that may interfere with the study results or prevent the participant from fully participating in the study, or any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment because of potential risks.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Man Hu

CONTACT

+8615806698606; hu5770@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is an open-label, randomized, two-arm parallel-group trial. Eligible subjects are randomly assigned in a 1:1 ratio to receive either proton-beam radiotherapy plus temozolomide or conventional photon radiotherapy plus temozolomide.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)