Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)

NCT07338526 | Recruiting DMC

• 1 other identifier: 4785
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Brain tumor, Benign; Brain tumor, Pediatric

Outcome Measures

Primary Outcomes (1)

• Survival Outcome

  Qualified Overall Survival (qOS) is a composite endpoint defined as survival without functional, cognitive, or quality-of-life deterioration, irrespective of whether the cause is disease progression or treatment toxicity. The study hypothesizes that IMPT is superior to IMRT for 5-year qOS. qOS is measured from randomization to the earliest of: 1. death from any cause; 2. radiological progression confirmed on multiparametric MRI with two scans ≥12 weeks apart or deemed progressive by multidisciplinary consensus; 3. neurocognitive decline \>10 IQ points on Wechsler scales; 4. clinically significant hypopituitarism requiring hormonal supplementation (CTCAE v5 Grade ≥2); 5. Grade ≥2 ototoxicity; or 6. symptomatic radiation necrosis requiring corticosteroids \>4 weeks or anti-angiogenic therapy (e.g., bevacizumab).

  5 years

Secondary Outcomes (6)

• Overall Survival (OS)

  At 5 years

• Progression-free Survival (PFS)

  at 5 years

• Quality of Life indices

  Pre-Radiotherapy (Baseline), Radiotherapy conclusion- within 1 week, 3-months post RT, 1-year post RT, annually till 5-years

• Cost-effectiveness based on EQ-5D-5L derived utilities

  Pre-Radiotherapy (Baseline), Radiotherapy conclusion- within 1 week, 3-months post RT, 1-year post RT, annually till 5-years

• Response Rate (RR)

  Radiotherapy conclusion- within 1 week, 3-months post RT, 1-year post RT, annually till 5-years

Study Arms (2)

Control Arm

OTHER

Patients in the standard arm will undergo focal cranial radiotherapy using photons (X-rays) with Image Guided Intensity Modulated Radiotherapy(IG-IMRT) using Volumetric Modulated Arc Therapy(VMAT).

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

Experimental Arm

EXPERIMENTAL

The patients in the experimental arm will undergo focal radiotherapy to an equivalent dose using protons with pencil beam scanning- IMPT or volumetric modulated proton arc therapy.

Radiation: Intensity-modulated proton therapy (IMPT)

Interventions

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

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.

Control Arm

Intensity-modulated proton therapy (IMPT) RADIATION

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.

Experimental Arm

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age at irradiation: 6 to 16 years
• Karnofsky/ Lansky Play Performance Status ≥ 60
• Diagnosis (histopathological/ radiological) of primary brain tumor with an expected survival of \>5 years (e.g., circumscribed gliomas, low grade gliomas, low-grade glial/ glioneuronal tumors, meningioma, pituitary tumors, schwannoma, craniopharyngioma, ependymoma)
• Planned for focal cranial radiotherapy
• Informed consent taken

You may not qualify if:

• Re-irradiation
• Palliative radiotherapy
• Multifocal or multicentric disease
• Planned for whole brain irradiation or craniospinal irradiation
• Planned for hypo-fractionated or stereotactic radiotherapy

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Abhishek Chatterjee, MD

CONTACT

2224177000; chatterji08@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, Phase 3 superiority, 2-arm, randomized controlled trial

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 14, 2026
• Study Start: August 7, 2025
• Primary Completion (Estimated): July 7, 2035
• Study Completion (Estimated): July 7, 2035
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)