Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Local Consolidative Radiation therapy plus TKI: Patients will receive local consolidative radiation therapy to all oligometastatic sites plus radiation therapy to primary disease
Contro
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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;
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine progression free survivalTimepoint: Median | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To determine overall survival 2)To evaluate local control rates of oligometastatic sites 3)To evaluate patient reported outcomes 4)To document treatment related toxicity Timepoint: median and at 2 years | — |
Countries
India
Contacts
Public ContactAnil Tibdewal
Tata Memorial Hospital
Outcome results
None listed