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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Tata Memorial Hospital
RECRUITING
Mumbai
Contact Information
Primary
Tejpal Dr Gupta, MD
tejpalgupta@rediffmail.com
(022) 2417 6015
Time Frame
Start Date: 2020-08-13
Estimated Completion Date: 2030-07
Participants
Target number of participants: 30
Treatments
Experimental: Low Dose Craniospinal Irradiation
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.
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov