Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in India / NCT04474964
Recruiting Not applicable

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

NCT04474964 · tracked via the Priya Life Science India tracker
Sponsor
Tata Memorial Centre
Phase
Not applicable
Started
2020-08-13
Last updated
2025-04-09

Condition(s) studied

Medulloblastoma, WNT-activated

Investigational drug(s) / intervention(s)

Low dose Craniospinal Irradiation plus Focal Radiotherapy

Low dose Craniospinal Irradiation plus Focal Radiotherapy: The 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.

Study 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 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
16 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Relapse-free survival will be analysed using using the product-limit method of Kaplan-Meier and compared using the log-rank test. — 5 years
    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. — 5 years
    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.

Trial sites (1)

FacilityCityRegionStatus
Tata Memorial Hospital Mumbai Maharashtra Recruiting

More Tata Memorial Centre trials in India

Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT) Recruiting
Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II/III Integrated Design Randomized Control Trial Starting soon
Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI Recruiting
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer Recruiting
Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04474964 on ClinicalTrials.gov ↗ ← All trials in India