NCT04474964 Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Medulloblastoma.
| NCT ID | NCT04474964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Medulloblastoma, WNT-activated |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-08-13 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2020-08-13 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04474964 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 16 Years, studying Medulloblastoma, WNT-activated. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04474964 currently recruiting?
Yes, NCT04474964 is actively recruiting participants. Contact the research team at tejpalgupta@rediffmail.com for enrollment information.
Where is the NCT04474964 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT04474964 clinical trial?
NCT04474964 is sponsored by Tata Memorial Centre. The trial plans to enroll 30 participants.