Addition of consolidative radiation therapy to TKI versus TKI alone in driver mutated lung cancer patients
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2019/11/021872
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1)Patients with pathologically proven diagnosis of NSCLC
2)Patients with positive oncogene driver mutation (EGFR or ALK/ROS)
3)Patients who have received at least 2-4 months of TKI therapy without progression
4)Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
5)Patients suitable for local consolidative therapy
6)Adequate end organ function
CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:
�Absolute neutrophil count (ANC) � 500 cells/mm3;
�Platelets � 50,000 cells/mm3;
�Hemoglobin � 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb � 8.0 g/dl is acceptable);
7)Patients with ECOG performance status of 0-2
8)Age > 18 years
9)For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;
1)Patients with progressive disease after 2-3 months of initial TKI therapy
2)Patients with negative oncogene driver mutations (EGFR/ALK/ROS)
3)Patients not suitable for local consolidative radiation therapy
4)Patients who are not suitable for further continuation of TKI therapy due to toxicity
5)Severe, active co-morbidity defined as follows:
�Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
�Transmural myocardial infarction within the last 6 months;
�Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
6)Patients with prior history of radiation therapy to thorax
7)Patients with second malignancy (Synchronous or Metachronous)
8)Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine progression free survivalTimepoint: Median
- Secondary Outcome Measures
Name Time Method 1)To determine overall survival <br/ ><br>2)To evaluate local control rates of oligometastatic sites <br/ ><br>3)To evaluate patient reported outcomes <br/ ><br>4)To document treatment related toxicity <br/ ><br>Timepoint: median and at 2 years