Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)

Summary

Children diagnosed with benign or low-grade brain tumors often require radiation therapy to control their disease. While radiation can be effective, traditional techniques using X-rays (photon-based radiotherapy) expose healthy brain tissue to radiation, potentially leading to long-term side effects like memory loss, learning difficulties, hormone imbalances, hearing problems, and a higher risk of secondary cancers. This study, called the IMPORT Trial, aims to compare two types of radiation therapy-Intensity-Modulated Proton Therapy (IMPT) and Intensity-Modulated Radiation Therapy (IMRT)-to determine which is safer and more effective for children. IMPT, a newer technique, uses protons instead of X-rays to deliver radiation, reducing exposure to healthy brain tissue. Researchers believe this could help minimize long-term damage while maintaining effective tumor control.

What is the goal of the study?

The primary goal is to see if IMPT leads to better survival with fewer side effects compared to IMRT. The study will track how well children function over five years, looking at:

* Cognitive abilities (memory, attention, learning)
* Hormonal balance (pituitary gland function)
* Hearing ability
* Overall survival without significant decline in quality of life

How will the study work?

* Who can join? Children aged 6 to 16 years diagnosed with certain types of benign or low-grade brain tumors.
* How are patients treated? Patients will be randomly assigned to receive either IMRT or IMPT.
* What is analysed? Doctors will track survival, tumor control, cognitive function, endocrine health, and quality of life over time.
* How long will it take? The study will last 10 years (5 years to enroll patients, 5 years to follow up).

Proton therapy is more expensive and not widely available, so strong scientific evidence is needed to justify its use in routine treatment. If IMPT significantly improves quality of life and survival, it could become the preferred treatment, shaping future policies and making proton therapy more accessible for children who need it.

Conditions

• Brain Tumor, Pediatric

Interventions

RADIATION

Intensity-modulated proton therapy (IMPT)

Patients in the experimental arm will receive focal cranial radiotherapy using proton therapy delivered with IMPT or proton arc techniques. Dose prescriptions and volumes will match institutional standards independent of study allocation. Planning will include CT and MRI fusion, with target and OAR delineation identical to the control arm. Proton plans will use robust optimization and undergo multidisciplinary review. Treatment will be delivered with image guidance, with weekly toxicity monitoring and standard clinical and imaging follow-up.

RADIATION

Photon-based intensity-modulated radiation therapy (IMRT).

Patients in the control arm will receive focal cranial radiotherapy using photon-based IG-IMRT delivered with VMAT. Dose, fractionation, and target volumes will follow standard institutional protocols based on tumor type and molecular features. Planning CT and MRI fusion will guide contouring of GTV, CTV, PTV, and organs at risk. Treatment plans will be generated in the Treatment Planning System and reviewed in multidisciplinary meetings. Radiotherapy will be delivered on IGRT-equipped linear accelerators, with weekly assessments for acute toxicities and routine follow-up imaging as per standard care.

Sponsors & Collaborators

• Tata Memorial Centre

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-07

Primary Completion

2035-07-07

Completion

2035-07-07

Countries

• India

Study Locations