Diffuse Intrinsic Pontine Gliomas (DIPG)Phase 3NCT07869524

IMPT Versus IMRT for Diffuse Intrinsic Pontine Glioma

A Phase 3 study testing Intensity-Modulated Proton Therapy (IMPT) and Intensity-Modulated Radiation Therapy (IMRT) in people with Diffuse Intrinsic Pontine Gliomas (DIPG), run by Shandong Cancer Hospital and Institute at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 3 to 18 years
Conditions the study is for: Diffuse Intrinsic Pontine Gliomas (DIPG)
What is being tested?: Intensity-Modulated Proton Therapy (IMPT) and Intensity-Modulated Radiation Therapy (IMRT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteChina
Study dates: 1 Dec 2026to 31 Dec 2031
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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:

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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.

Who cannot join

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.

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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:
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Man Hu contact

+8615806698606

hu5770@sina.com

China1 site

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, 250117
Man Hu, +8615806698606, hu5770@sina.com

Other trials in China

About this study

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)

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)
Being tested: Intensity-Modulated Proton Therapy (IMPT), Intensity-Modulated Radiation Therapy (IMRT)
Keywords: Diffuse intrinsic pontine glioma, Diffuse midline glioma, Intensity-modulated proton therapy, Intensity-modulated radiation therapy, DIPG
Medical subject headings: Diffuse Intrinsic Pontine Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 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.

Study groups in NCT07869524
Study group	Role	What they receive
Intensity-Modulated Proton Therapy (IMPT)	Experimental	Not described Receives: Radiation: Intensity-Modulated Proton Therapy (IMPT)
Intensity-Modulated Radiation Therapy (IMRT)	Active comparator	Not described Receives: Radiation: Intensity-Modulated Radiation Therapy (IMRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

1-Year Overall Survival (OS) Rate
Measured: 1 year after randomization

Secondary outcomes (3)

1-Year Progression-Free Survival (PFS) Rate
The proportion of participants who are alive without disease progression at 1 year after initiation of study treatment.
Measured: 1 year after initiation of study treatment
Incidence of Treatment-Related Adverse Events
Incidence and severity of treatment-related adverse events and serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: From initiation of study treatment through 30 days after completion of study treatment
Change in Pediatric Quality of Life Inventory (PedsQL) Scores
Quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and PedsQL Brain Tumor Module. Changes in PedsQL scores over time will be evaluated.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202631 Dec 2031

First posted9 Oct 2026
Study start1 Dec 2026 (estimated)
Primary completion31 Dec 2030 (estimated)
Study completion31 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diffuse Intrinsic Pontine Gliomas (DIPG)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 142 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07869524
Sponsor's protocol ID: imPRO-DIPG-01
Status last verified: Oct 2026
First submitted: 20 Aug 2026
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Man Hu

+8615806698606

hu5770@sina.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Diffuse Intrinsic Pontine Gliomas (DIPG) trials