Role of Copper in addition to whole brain radiotherapy in brain metastases in lung cance
Phase 2
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2020/09/027794
- Lead Sponsor
- Jai Prakash Agarwal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age >= 18 years
2. Patients with ECOG performance status of 0-2
3. Patients with histologic or cytologic diagnosis of NSCLC
4. Patients with radiologically measurable brain metastases
5. Patients planned for systemic therapy
6. Patients willing for written informed consent and must be willing to comply with the specified follow up schedule
7. Signed written informed consent
Exclusion Criteria
1)Patients with leptomeningeal dissemination without measurable parenchymal brain metastases
2)Patients with brain metastases in the brain stem
3)Patients with prior history of radiation therapy to brain
4)Pregnant or lactating females
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the intracranial progression free survivalTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method 1)To determine overall survival <br/ ><br>2)To compare ORR of brain metastases <br/ ><br>3)To compare treatment related toxicity <br/ ><br>4)To determine the various prognostic factors for iPFS and OS <br/ ><br>5)To evaluate patient reported outcomes <br/ ><br>Timepoint: at 3, 6 and 12 months