Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis

NCT05144867 | Unknown Phase 3 DMC

• 1 other identifier: NK/7784/Study/249
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Brain Metastases, Adult; Stereotactic Radiosurgery; Whole Brain Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of randomization till death due to breast cancer

  1 year

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  1 year

• Quality of Life - KPS

  Base line and 6 months

• Quality of life - MINI MENTAL STATE

  Base line and 6 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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.

Radiation: Stereotactic Radiosurgery

Arm 2

EXPERIMENTAL

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.

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

All patients to undergo planning CT simulation with 1mm slice thickness. For all lesions, the gross tumor volume (GTV) will be defined as the visible tumor on CT and/or MRI imaging. A Planning Target Volume (PTV) margin of 2-5 mm will be added. Organs at risk visible in the planning CT scan will be contoured. The doses will be prescribed to approximately 100% isodose level and 95% of the PTV should receive 95% of the prescription dose. 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.

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years
• Willing to provide informed consent
• Histologically confirmed malignancy with metastatic disease detected on imaging.
• ECOG performance status 0-1
• to 3 brain metastases, each with a maximum diameter of no more than 3 cm on contrast enhanced magnetic resonance imaging(MRI) scans

You may not qualify if:

• Serious medical comorbidities
• ECOG \>= 2
• Prior Brain Radiotherapy
• \>3 brain metastasis
• Maximum diameter \>4cm on MRI

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Budhi Singh Yadav

Chandigarh, 160012, India

RECRUITING

Related Publications (2)

• Gupta A, Yadav BS, Ballari N, et al. LINAC-based stereotactic radiosurgery/radiotherapy for brain metastases in patients with breast cancer. Journal of Radiotherapy in Practice , Volume 21 , Issue 3 , September 2022 , pp. 351 - 359 DOI: https://doi.org/10.1017/S1460396921000029[Opens in a new window]

  BACKGROUND

• Yadav BS, Vias P, Robert N, Gade VKV, Kajla A. Whole Brain Radiotherapy Versus Stereotactic Radiosurgery in Breast Cancer Patients With Brain Metastases-A Phase 3 Open Label Randomized Study. Asia Pac J Clin Oncol. 2025 Sep 22. doi: 10.1111/ajco.70029. Online ahead of print.

  PMID: 40983872 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Budhi Singh Yadav, MD

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Budhi Singh Yadav, MD

CONTACT

drbudhi@gmail.com

Budhi Singh Yadav, MD

CONTACT

0172275; drbudhi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 3, 2021
• Study Start: August 31, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)