Safety and efficacy of Stereotactic Radiotherapy in brain metastasis in case of non small cell lung cancer .
- Conditions
- Health Condition 1: D024- Carcinoma in situ of respiratory system, unspecified
- Registration Number
- CTRI/2022/02/040576
- Lead Sponsor
- AIIMS NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. NSCLC (pathologic confirmation) with 1-4 brain metastasis all smaller than 3 cm in diameter.
2. Adult patients (>=18 years of age),
3. Eastern Cooperative Oncology Group[ECOG] performance status <=2
4. Graded Prognostic Assessment (GPA) >=1.5
5. All standard tumour-staging procedures necessary to define baseline extracranial disease status
6. Systemic treatment as per institute guidelines and physician discretion.
1.Pregnant women
2.Inability to complete a magnetic resonance imaging scan with contrast
3.Prior resection of cerebral metastasis
4.Chemotherapy within 7 days of preregistration or planned chemotherapy during the radiotherapy
5.Prior cranial radiotherapy
6.Pacemaker or other MRI non-compatible metal in the body
7.Known allergy to gadolinium
8.Leptomeningeal metastases
9.Lesion located within 5 mm of the optic chiasm or within the brainstem
10.Inability to undergo contrast enhanced computed tomography
11.Inability to give consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intracranial tumour control rates. <br/ ><br>Neuro cognitive decline .Timepoint: Intracranial tumor control rate at 3 months <br/ ><br>Neuro congnitive assessment at 4 weeks.
- Secondary Outcome Measures
Name Time Method â?¢Cognitive outcomes for individual cognitive assessments: Defined as a decline of greater than 1 SD from baseline on cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post treatment evaluation.Timepoint: 3 monnths