Comparing Stereotactic Radiosurgery and Whole Brain Radiotherapy for Breast Cancer with Brain Metastases
Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis- A Randomised Controlled Phase 3 Trial
This study is testing whether Stereotactic Radiosurgery or Whole Brain Radiotherapy helps breast cancer patients with brain metastases live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pgimer |
| Drugs / interventions | radiation |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT05144867 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of Stereotactic Radiosurgery (SRS) versus Whole Brain Radiotherapy (WBRT) in improving overall survival and quality of life for breast cancer patients with oligometastatic brain disease. A total of 98 patients will be enrolled, with treatment regimens tailored based on the size and number of brain metastases. The study aims to assess not only survival rates but also the toxicity of radiation and the impact on patients' quality of life. Patients will be randomized and stratified based on their specific clinical characteristics before treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed breast cancer and 1 to 3 brain metastases, each measuring no more than 3 cm.
Not a fit: Patients with serious medical comorbidities, prior brain radiotherapy, or more than 3 brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for breast cancer patients with brain metastases, potentially improving survival and quality of life.
How similar studies have performed: Previous studies have shown promising results with SRS in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Serious medical comorbidities * ECOG \>= 2 * Prior Brain Radiotherapy * \>3 brain metastasis * Maximum diameter \>4cm on MRI
Where this trial is running
Chandigarh
- Budhi Singh Yadav — Chandigarh, India (Recruiting)
Study contacts
- Principal investigator: Budhi Singh Yadav, MD — PGIMER, Chandigarh
- Study coordinator: Budhi Singh Yadav, MD
- Email: drbudhi@gmail.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.