Status:

RECRUITING

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

Lead Sponsor:

Tata Memorial Centre

Conditions:

Medulloblastoma, WNT-activated

Eligibility:

All Genders

3-16 years

Phase:

NA

Brief Summary

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 ...

Detailed Description

WNT pathway medulloblastomas have the best prognosis amongst all four subgroups with 5-year overall survival exceeding 90%. Overall medulloblastoma is more common in males. They can occur at all ages,...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 13 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2030

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04474964

Start Date

August 13 2020

End Date

July 1 2030

Last Update

April 9 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Tata Memorial Hospital

Mumbai, Maharashtra, India, 400012

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