To assess the side-effects and effectiveness of altered fractionation radiotherapy without chemotherapy in medulloblastoma

Phase 1

Completed

• Registration Number: CTRI/2009/091/000521
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Paediatric patients of either sex aged between 5 ? 18 yrs. of age
2.Histologically confirmed diagnosis of medulloblastoma
3.Average risk disease
4.Karnofsky performance status of ≥ 70%
5.Signed informed consent
6.Patient suitable for undergoing twice daily radiotherapy
7.Radiotherapy starting within 4-6 weeks of surgery.

Exclusion Criteria

1.Patients with recurrent tumors
2.Prior history of therapeutic irradiation
3.Prior/ concurrent second neoplasm
4.Known predisposition to medulloblastoma
5.High risk disease
6.Any form of immunosuppression e.g.
7.Patients requiring anaesthesia during RT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of implementing a quality assured technique of CSI followed by conformal boost with HFRT and HART using customized immobilization in the pediatric population requiring CSI.<br><br>Timepoint: ;To assess the feasibility of implementing a quality assured technique of CSI followed by conformal boost with HFRT and HART using customized immobilization in the pediatric population requiring CSI.<br><br>Timepoint:

Secondary Outcome Measures

Name	Time	Method
As secondary outcomes the target volume coverage and conformity of CT based planning shall be compared with conventional simulator based planning. These secondary outcomes shall be reported within 6 months of accrual of the last patients. As a tertiary endpoint, the event ?free survival, overall survival & the decline in neuro-congnitive outcome at 2 years shall compared to historical controls and reported accordingly after a minimal follow up of 2 years.Timepoint: ;As secondary outcomes the target volume coverage and conformity of CT based planning shall be compared with conventional simulator based planning. These secondary outcomes shall be reported within 6 months of accrual of the last patients. As a tertiary endpoint, the event ?free survival, overall survival & the decline in neuro-congnitive outcome at 2 years shall compared to historical controls and reported accordingly after a minimal follow up of 2 years.Timepoint: