Clinical trial · Interventional
Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis
Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis- A Randomised Controlled Phase 3 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Stereotactic Radiosurgery | — | UNRESOLVED | — |
| Whole Brain Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- 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.
- interventionNames
- Radiation: Stereotactic Radiosurgery
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- 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.
- interventionNames
- Radiation: Stereotactic Radiosurgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDGupta 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]
- DERIVEDYadav 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. 2026 Jun;22(3):435-446. doi: 10.1111/ajco.70029. Epub 2025 Sep 22. PMID 40983872