Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis- A Randomised Controlled Phase 3 Trial

Who is this study for? Patients with breast cancer with brain oligometastasis
What treatments are being studied? Stereotactic radiosurgery
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This trial aims to assess the impact of SRS on overall survival, PFS, radiation toxicity and quality of life as compared to WBRT in oligometastatic brain disease in breast cancer patients. Total 98 patients with breast cancer with brain oligo-metastases will be included. The WBRT dosage schedule will be 30 Gy in 10 fractions over 2 weeks. For tumors with 2cm, SRS dose of 22 to 25 Gy will be delivered and tumor larger than 2 cm will be treated with doses of 18 to 20 Gy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age \>=18 years

• Willing to provide informed consent

• Histologically confirmed malignancy with metastatic disease detected on imaging.

• ECOG performance status 0-1

• 1 to 3 brain metastases, each with a maximum diameter of no more than 3 cm on contrast enhanced magnetic resonance imaging(MRI) scans

Locations
Other Locations
India
Budhi Singh Yadav
RECRUITING
Chandigarh
Contact Information
Primary
Budhi Singh Yadav, MD
drbudhi@gmail.com
Backup
Budhi Singh Yadav, MD
drbudhi@gmail.com
0172275
Time Frame
Start Date: 2021-08-31
Estimated Completion Date: 2024-03-31
Participants
Target number of participants: 98
Treatments
Active_comparator: Arm 1
The WBRT dosage schedule will be 30 Gy in 10 fractions over 2 weeks. For Arm 1, Treatment planning is to be done using CT simulation or conventional simulation (fluoroscopy). Simple beam arrangements, such as parallel opposed beams, will be favoured wherever possible.
Experimental: Arm 2
Metastases with a maximum diameter of up to 2 cm will be treated with doses of 22 to 25 Gy and those larger than 2 cm will be treated with doses of 18 to 20 Gy.
Related Therapeutic Areas
Breast Cancer
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov

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