Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT): A Phase 3 Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Tata Memorial Hospital
RECRUITING
Mumbai
Contact Information
Primary
Abhishek Chatterjee, MD
chatterji08@gmail.com
2224177000
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2035-07-07
Participants
Target number of participants: 94
Treatments
Other: Control Arm
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).
Experimental: Experimental Arm
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.
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov