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Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Medulloblastoma.

RecruitingNAAges 3 Years - 16 YearsAllTata Memorial Centre
NCT04474964 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Fit for initiation of adjuvant treatment within 6-weeks of surgery Exclusion Criteria: * 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. * Previous history of radiotherapy or chemotherapy prior to study enrollment. * Not fit for initiation of adjuvant treatment within 6 weeks of surgery. * Not willing for consent/assent.
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What it tests

  • Low dose Craniospinal Irradiation plus Focal Radiotherapy
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Where

1 site
Tata Memorial Hospital
Mumbai, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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