Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

Proton Beam Therapy: Patients randomized to the experimental arm will be treated with proton beam therapy.

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

Study 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.

Eligibility

Primary outcome measure(s)

• 5-year functional survival — 7 years
  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

Trial sites (1)

More Tata Memorial Centre trials in India

Other trials for the same condition