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

NCT04474964 | Recruiting DMC

• 1 other identifier: 3468
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Medulloblastoma, WNT-activated

Keywords

WNT medulloblastoma; low dose craniospinal irradiation; overall survival; long term toxicities

Outcome Measures

Primary Outcomes (2)

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

  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).

  5 years

• Overall Survival of Participants will be analysed using the product-limit method of Kaplan-Meier and compared using the log-rank test.

  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.

  5 years

Secondary Outcomes (6)

• Neuro-cognitive function of Participants will be analysed longitudinally over time using linear regression model with time-test for trend

  5 years

• Growth Hormone levels of Participants will be analysed longitudinally over time using linear regression model with time-test for trend.

  5 years

• Thyroid function levels of Participants will be analysed longitudinally over time using linear regression model with time-test for trend.

  5 years

• Cortisol levels of Participants will be analysed longitudinally over time using linear regression model with time-test for trend.

  5 years

• Sex Hormone levels of Participants will be analysed longitudinally over time using linear regression model with time-test for trend.

  5 years

Study Arms (1)

Low Dose Craniospinal Irradiation

EXPERIMENTAL

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.

Radiation: Low dose Craniospinal Irradiation plus Focal Radiotherapy

Interventions

Low dose Craniospinal Irradiation plus Focal Radiotherapy RADIATION

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.

Low Dose Craniospinal Irradiation

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Medulloblastoma

Interventions

Craniospinal Irradiation

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Central Study Contacts

Tejpal Dr Gupta, MD

CONTACT

(022) 2417 6015; tejpalgupta@rediffmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: August 13, 2020
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)