eoadjuvant chemotherapy in NSCLC
Phase 2
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lungHealth Condition 2: null- stage 2b and 3 Non Small Cell Lung Cancer
- Registration Number
- CTRI/2016/05/006916
- Lead Sponsor
- investigator initiated study
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Pathological diagnosis of NSCLC
2.Age 18 to 75 years
3.ECOG PS 0-2
4.Local disease T3 (with > 5cm contact with chest wall) or T4
5.Mediastinal stage N0, N1 or non bulky N2 (defined as single station N2 station node <2 cms in size or multiple matted nodes but < 2cm at single N2 station) documented on PET scan and EBUS TBNA
Exclusion Criteria
1.ECOG PS >2
2.Gross mediastinal structures invasion
3.SVCO
4.Immunocompromised
5.Multiple comorbidities precluding possibilty of surgery
6.Poor PFT (predicted post operative FEV1 < 800 cc not suitable for single lung anaesthesia)
7.Pregnent and lactating females
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oRdiological response rates with neoadjuvant chemotherapyTimepoint: At the end of Four cycle of chemotherapy
- Secondary Outcome Measures
Name Time Method 1.Improvement in resectability, (pnemonectomy converted to conservative surgery) <br/ ><br>2.Toxicity profile assessment <br/ ><br>3.Progression free survival (from date of enrollment till date of disease progression or death ) <br/ ><br>4.Post operative/ operarive complications <br/ ><br>Timepoint: 1. At the end of neoadjuvent chemotherapy. <br/ ><br>2. At the end of the therapy.