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

NCT05144867 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-10-17

No results posted yet for this study

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

Interventions

RADIATION

Stereotactic Radiosurgery

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.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Budhi Singh Yadav, MD · PGIMER, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144867 on ClinicalTrials.gov