Health TrialsbyHealthPanel

Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors

ConditionsPrimary Brain TumorsDiffuse GliomaMeningiomaPituitary AdenomaLow Grade CNS Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTata Memorial Centre

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

Re-irradiation

Palliative radiotherapy

Multifocal or multicentric disease

Planned for whole brain irradiation or craniospinal irradiation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proton Beam Therapy

    Radiation

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

  • Photon Radiotherapy

    Radiation

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

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Photon therapy (standard arm)Other 1 intervention
Group B: Proton beam therapy (experimental arm)Experimental treatment 1 intervention

Trial outcomes

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

Time frame
7 years

Secondary outcomes

1

Overall Survival

Overall survival will be calculated using Kaplan Meier method with death from any cause considered as an event.

Time frame
7 years
2

Progression free survival

Progression free survival will be calculated using Kaplan Meier method with disease progression considered as an event.

Time frame
7 years
3

Acute radiation toxicity

The cumulative incidence of acute radiation toxicity (upto 90 days from completion of radiotherapy) will be compared between the two study arms using Chi-square test

Time frame
7 years
4

Quality of life core questionnaire

The European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) core questionnaire (C30) will be used. The summary scores will be calculated from the raw scores as per the manual, ranging from 0 to 100, with higher scores representing better outcomes. The global score and scores of subdomains will be calculated during follow-up and compared with baseline.

Time frame
7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Centre

Lead sponsor

Source ClinicalTrials.gov
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