Combining low dose craniospinal irradiation with focal radiotherapy for children with WNT medulloblastoma
Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Subgroup Medulloblastoma.
This study is testing a new way to treat children with a specific type of brain tumor by using lower doses of radiation to see if it can help them get better while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT04474964 on ClinicalTrials.gov |
What this trial studies
This clinical study focuses on treating children diagnosed with WNT pathway medulloblastoma, a type of brain tumor known for its favorable prognosis. The approach involves administering low dose craniospinal irradiation alongside focal radiotherapy, aiming to reduce long-term side effects associated with higher radiation doses while maintaining effective disease control. The study seeks to evaluate the safety and efficacy of this de-intensified treatment strategy in newly diagnosed patients. By carefully selecting participants based on specific eligibility criteria, the study aims to optimize treatment outcomes for this low-risk group.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 16 years with newly diagnosed WNT pathway medulloblastoma and minimal post-surgery residual disease.
Not a fit: Patients outside the age range of 3 to 16 years or those with other molecular subgroups of medulloblastoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce long-term toxicities in children treated for WNT medulloblastoma without compromising their survival rates.
How similar studies have performed: Other studies have explored de-intensification strategies in similar patient populations, showing promising results in reducing treatment-related toxicities.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial Hospital — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Study coordinator: Tejpal Dr Gupta, MD
- Email: tejpalgupta@rediffmail.com
- Phone: (022) 2417 6015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.