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IMPT Versus IMRT for Diffuse Intrinsic Pontine Glioma

ConditionDiffuse Intrinsic Pontine Gliomas (DIPG)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-18
SponsorShandong Cancer Hospital and Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Intensity-Modulated Proton Therapy (IMPT)Experimental treatment 1 intervention
Group B: Intensity-Modulated Radiation Therapy (IMRT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

1-Year Overall Survival (OS) Rate

Time frame
1 year after randomization

Secondary outcomes

1

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.

Time frame
1 year after initiation of study treatment
2

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.

Time frame
From initiation of study treatment through 30 days after completion of study treatment
3

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.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Cancer Hospital and Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: