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Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis (SRSvsWBRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05144867
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Budhi Singh Yadav, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Brain Metastases, Adult Stereotactic Radiosurgery Whole Brain Radiotherapy Radiation: Stereotactic Radiosurgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis- A Randomised Controlled Phase 3 Trial
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Arm 1
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
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.

Experimental: Arm 2
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
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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    From date of randomization till death due to breast cancer


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 1 year ]
    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.

  2. Quality of Life - KPS [ Time Frame: Base line and 6 months ]
    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.

  3. Quality of life - MINI MENTAL STATE [ Time Frame: Base line and 6 months ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05144867


Locations
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India
Budhi Singh Yadav Recruiting
Chandigarh, India, 160012
Contact: BUDHI S YADAV    9815981176    drbudhi@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
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Responsible Party: Dr Budhi Singh Yadav, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT05144867    
Other Study ID Numbers: NK/7784/Study/249
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases