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

Optimizing the physical and biological parameters in craniospinal irradiation (CSI) for average risk medulloblastoma: a feasibility study. - Nil

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000521

Enrollment

Registered

2009-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Radiation therapy: NA Control Intervention1: Not applicable: Control Intervention2: Not applicable:

Eligibility

Inclusion criteria

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 &#8805; 70% 5.Signed informed consent 6.Patient suitable for undergoing twice daily radiotherapy 7.Radiotherapy starting within 4-6 weeks of surgery.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 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. Timepoint:	—

Measure

Time frame

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. 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. Timepoint:

—

Secondary

Measure	Time frame
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:	—

Measure

Time frame

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:

—

Countries

India

Contacts

Public ContactDr. T. Gupta

Tata Memorial Centre Tata Memorial Hospital and ACTREC

tgupta@actrec.gov.in912227405057

Outcome results