Proton versus Photon Radiotherapy In Adults with primary brain tumors Evaluating functional survival A Phase 3 Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Primary endpoint
Study Overview
Brief Summary
This study will be done in adults with brain tumors having good life expectancy requiring treatment with radiotherapy. The current practice for brain radiotherapy involves an advanced technique of radiation using X rays (photon radiotherapy). Another newer technology for delivering radiation is available called proton beam therapy, which allows to reduce the lower dose of radiation to the parts pf brain surrounding the tumor. After treatment with photon radiotherapy certain late effects of radiation like memory decline, hormonal deficits, hearing loss, worsening of neurological function can occur in some patients. From evaluation of dose profiling, proton beam therapy has potential to reduce the possibility of side effects by reducing dose to critical organs. However, there is no clinical data to demonstrate whetherthe 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Primary brain tumors
- •Age at irradiation 18 to 70 years
- •Karnofsky Performance Status more than 60
- •Diagnosis histopathological radiological of primary brain tumor with an expected survival of above 5 years
- •Planned for focal cranial radiotherapy
- •Informed consent taken.
Exclusion Criteria
- •Reirradiation
- •Palliative radiotherapy
- •Multifocal or multicentric disease
- •Planned for whole brain irradiation or craniospinal irradiation
- •Planned for hypofractionated or stereotactic radiotherapy.
Outcomes
Primary Outcomes
Primary endpoint
Time Frame: 5 years
The 5 year rate of overall survival without functional deterioration functional survival equal to fS will be
Time Frame: 5 years
calculated from the date of randomization. An event concerning the primary endpoint will include
Time Frame: 5 years
Neurocognitive decline
Time Frame: 5 years
CTCAE grade 2 ototoxicity
Time Frame: 5 years
New neuroendocrine axis dysfunction or worsening of pre existing dysfunction
Time Frame: 5 years
Neurological and functional impairment
Time Frame: 5 years
CTCAE gr 3 radionecrosis
Time Frame: 5 years
Disease progression
Time Frame: 5 years
All cause mortality
Time Frame: 5 years
Secondary Outcomes
- Secondary endpoints:(1. Overall survival & Progression-free survival.)
Investigators
Dr ARCHYA DASGUPTA
Tata Memorial Hospital
