Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors

NCT06831461 | Recruiting DMC

• 1 other identifier: 4617
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be done in adults with brain tumors having good prognosis requiring treatment with radiotherapy. The current practice for brain radiotherapy involves treatment using X rays (photon radiotherapy). Proton beam therapy is a more advanced form of delivering radiation, which allows the reduction of the dose of radiation to the parts of the brain surrounding the tumor. After treatment with photon radiotherapy, certain late effects of radiation, like memory decline, hormonal deficits, hearing loss, and worsening of neurological function, can occur in some patients. From the evaluation of dose profiling, proton beam therapy has the potential to reduce the possibility of side effects by reducing the dose to critical organs. However, there is no clinical data to demonstrate whether the theoretical dose reduction translates to a clinically meaningful benefit. In the proposed study, 156 patients will be randomly allocated to either proton or photon radiotherapy in 1: 1 ratio. The primary objective of the study is to explore whether proton therapy improves functional survival, which is life expectancy without recurrence, death, or complications from radiotherapy.

Conditions

Primary Brain Tumors; Diffuse Glioma; Meningioma; Pituitary Adenoma; Low Grade CNS Tumors

Keywords

Proton Beam Therapy; Photon Radiotherapy; Brain Tumors; Neurocognition; Survival

Outcome Measures

Primary Outcomes (1)

• 5-year functional survival

  Functional survival will be calculated using Kaplan Meier method from the date of randomization as the primary outcome for the study. Any of the following will be considered as an event for the assessment of functional survival. 1. Cognitive decline: A drop of 10% from baseline in the FSIQ or any sub-domains of the neurocognition test. 2. CTCAE v.5 gr ≥2 ototoxicity: Threshold shift of \>25 dB averaged at 2 or more contiguous test frequencies in at least one ear (on a 1, 2,3,4,6 and 8kHz audiogram) or decrease in hearing to profound bilateral loss. 3. Endocrinal dysfunction: Significant decline in one or multiple pituitary axes and/or starting/increasing dose of hormone supplements. 4. Neurological impairment: A decrease in the NPS by 2 points or KPS by atleast 30 points from pre-radiation status. 5. CTCAE gr ≥3 radio-necrosis 6. Disease progression 7. Death

  7 years

Secondary Outcomes (6)

• Overall Survival

  7 years

• Progression free survival

  7 years

• Acute radiation toxicity

  7 years

• Quality of life core questionnaire

  7 years

• Quality of life brain cancer module

  7 years

Study Arms (2)

Photon therapy (standard arm)

OTHER

Patients in the standard arm will undergo focal cranial radiotherapy using photons (X-rays) with image guidance using IMRT, VMAT, or helical intensity-modulated techniques.

Radiation: Photon Radiotherapy

Proton beam therapy (experimental arm)

EXPERIMENTAL

The patients in the experimental arm will undergo focal radiotherapy to an equivalent dose using proton beam therapy.

Radiation: Proton Beam Therapy

Interventions

Proton Beam Therapy RADIATION

Patients randomized to the experimental arm will be treated with proton beam therapy.

Proton beam therapy (experimental arm)

Photon Radiotherapy RADIATION

Patients randomized to standard arm will be treated with photon therapy.

Photon therapy (standard arm)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary brain tumors
• Age at irradiation: 18 to 70 years
• Karnofsky Performance Status ≥ 60
• Diagnosis (histopathological/ radiological) of primary brain tumor with an expected survival of \>5 years (e.g., grade 2-3 diffuse glioma, low-grade glial/ glioneuronal tumors, ependymoma, meningioma, pituitary tumors, schwannoma, craniopharyngioma, etc.)
• 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 Centre

Mumbai, India

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Meningioma; Pituitary Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Central Study Contacts

Archya Dasgupta, MBBS MD

CONTACT

8097081506; archya1010@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Department of Radiation Oncology

Model Details: Prospective, open-label, superiority, 2-arm, randomized controlled trial, phase 3 study.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)