Breast Cancer Clinical Trial
— SRSvsWBRTOfficial title:
Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis- A Randomised Controlled Phase 3 Trial
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.
Status | Recruiting |
Enrollment | 98 |
Est. completion date | March 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Budhi Singh Yadav | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
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]
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | From date of randomization till death due to breast cancer | 1 year | |
Secondary | Progression Free Survival (PFS) | From completion of radiotherapy treatment to intracranial progression of disease on MRI/CT scan as per the RECIST criteria which is >20% increase(>5mm absolute increase) in the the sum of the longest diameters in comparison with the smallest sum of the longest diameters recorded since treatment started. | 1 year | |
Secondary | Quality of Life - KPS | At each visit, functional status and neurologic toxic effects will be scored. Systemic functional status will be evaluated by using the KPS score. KPS will be scored 80-100 if the patient is able to carry on normal activity and to work without special care. A score of 50-70 will indicate patient is unable to work; live at home and care for most personnel needs; varying amount of assistance required. A score of 10-30 indicate that unable to care for self; requires equivalent of hospital or institutional care; disease may be progressing rapidly. A score of 0 means patient is dead. Neurologic function will be evaluated according to the MINI MENTAL STATE EXAMINATION. Patients will be scored for each question from 0-30. Degree of impairment will be graded as severe if the score is 0-10, moderate if the score is 10-20, mild between 20-25 and questionable significant if the score is 25-30. | Base line and 6 months | |
Secondary | Quality of life - MINI MENTAL STATE | Neurologic function will be evaluated according to the MINI MENTAL STATE EXAMINATION. Patients will be asked a set of questions( for example what is the year? season? date? day? month?; where are we now? state? county? town? city? hospital?; spell WORLD back word or count D-L-R-O-W or count back word from 100 by seven- 93, 86, 79, 72, 65). Score 1 point for each correct response with in each question will be given so that a score from 0-30 is recorded. Degree of impairment will be graded as severe if the score is 0-10, moderate if the score is 10-20, mild between 20-25 and questionable significant if the score is 25-30. | Base line and 6 months |
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