This clinical study is going to be done on a type of brain tumor in children called Medulloblastoma. The WNT pathway type of medulloblastoma is considered to be low risk and have the best outcomes in terms of survival. With the current standard of care for this type of medulloblastoma it is believed by the investigators that we are over treating the disease and increasing the long term side effects of these children. Several groups in the world are testing de-intensification of treatment in this favourable subset of children who experience long term late side effects of therapy. By reducing the dose to the craniospinal axis and keeping the total tumor bed dose the same in this study the investigators are expecting to reduce some of the late side effects of craniospinal irradiation without compromising disease control and survival.
Age more than 3 years and less than 16 years.
Newly diagnosed WNT pathway medulloblastoma.
Post-surgery residual disease less than 1.5 cm2 on post-operative MRI brain.
No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF) assessed by MRI of the brain/spine and lumbar puncture for CSF cytology.
Age Less than 3 and more than 16 years.
Molecular subgroup other than WNT pathway.
Post-surgery residual disease more than 1.5cm2 on post-operative imaging.
Evidence of any metastatic disease in the brain, spine or CSF.
Single group
Low dose Craniospinal Irradiation plus Focal Radiotherapy
RadiationThe intervention arm of the study is to prospectively evaluate disease-related outcomes of low-dose CSI plus focal radiotherapy without concurrent chemotherapy followed by standard 6-cycles of adjuvant systemic chemotherapy in WNT-pathway medulloblastoma.
Relapse-free survival will be analysed using using the product-limit method of Kaplan-Meier and compared using the log-rank test.
Measure Relapse-free survival in WNT medulloblastoma treated with low-dose CSI plus focal radiotherapy without concurrent chemotherapy followed by standard 6-cycles of adjuvant systemic chemotherapy. Relapse free survival will be calculated from the date of surgery till the first documented clinico-radiological evidence of relapse (recurrence/progression).
Overall Survival of Participants will be analysed using the product-limit method of Kaplan-Meier and compared using the log-rank test.
Measure Overall survival in WNT medulloblastoma treated with low-dose CSI plus focal radiotherapy without concurrent chemotherapy followed by standard 6-cycles of adjuvant systemic chemotherapy.Overall survival will be measured from the date of diagnosis till death from any cause.
Neuro-cognitive function of Participants will be analysed longitudinally over time using linear regression model with time-test for trend
Neurocognitive Outcome will be assessed using Wechsler scale for children by comparing pre-radiotherapy result with assessment done 3-6 months after radiotherapy, at 1-year post-treatment, and annually thereafter till 5-years.
Growth Hormone levels of Participants will be analysed longitudinally over time using linear regression model with time-test for trend.
Serial Serum growth hormone(ng/ml) levels will be done by comparing pre-radiotherapy levels with biochemical assessment done 3-6 months after radiotherapy, at 1-year post-treatment and annually thereafter for 5-years.
Thyroid function levels of Participants will be analysed longitudinally over time using linear regression model with time-test for trend.
Serial Thyroid function levels : TSH , T3, T4 levels will be done by comparing pre-radiotherapy levels with biochemical assessment done 3-6 months after radiotherapy, at 1-year post-treatment and annually thereafter for 5-years.
Cortisol levels of Participants will be analysed longitudinally over time using linear regression model with time-test for trend.
Serial Cortisol levels (mcg/dl) will be done by comparing pre-radiotherapy levels with biochemical assessment done 3-6 months after radiotherapy, at 1-year post-treatment and annually thereafter for 5-years.
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