SBRT in extracranial oligometastatic disease and its impact on survival and quality of life.
Phase 2
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2023/02/049798
- Lead Sponsor
- PGIMER CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Lymph node, bone, liver, lung oligometastatic disease
2) All primary tumors of colorectal, gastric, esophagus, lung, breast, gynaecological cancers or any other site
3) A controlled primary tumor
4) A life expectancy of more than 6 months
5) KPS = 70
6) Age > 18 years
Exclusion Criteria
More than 5 metastases
2) KPS = 60
3) Pre-existing collagen vascular disease
4) Age < 18 years
5) Pregnant and Lactating women
6) Disseminated disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess effect of SBRT on <br/ ><br>1)Local control of oligometastatic site <br/ ><br>2)Overall survival <br/ ><br>Timepoint: At 6 months and 1 year
- Secondary Outcome Measures
Name Time Method 1)To assess Progression Free Survival and distant metastasis free survival <br/ ><br>2)To evaluate adverse events according to CTCAE <br/ ><br>3)To evaluate chemotherapy-free survival <br/ ><br>4)Quality of life assessment with EORTC QLC C30 <br/ ><br>Timepoint: At 3 months, 6 months, 9 months and one year