Clinical trial · Interventional
Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Medulloblastoma.
Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Subgroup Medulloblastoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medulloblastoma, WNT-activated | Medulloblastoma, WNT-Activated | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose Craniospinal Irradiation plus Focal Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low Dose Craniospinal Irradiation
- description
- WNT subgroup medulloblastoma patients accrued in the study will be treated with Low-dose Craniospinal Irradiation (18Gy/10fx) plus focal conformal tumor-bed boost (36Gy/20fx) for total primary-site dose of 54Gy/30fx over 6-weeks. Followed by adjuvant multi-agent systemic chemotherapy which will be initiated 4-6 weeks after completion of radiotherapy provided the ANC \>1500 and platelet count \>1,00,000. A total of 6 cycles of alternating chemotherapy every 4-weekly will be planned as per our standard practice using CET protocol.
- interventionNames
- Radiation: Low dose Craniospinal Irradiation plus Focal Radiotherapy
Primary outcomes (2)
- measure
- Relapse-free survival will be analysed using using the product-limit method of Kaplan-Meier and compared using the log-rank test.
- timeFrame
- 5 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available