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โ† Trials
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Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

RecruitingPhase 2Ages 18 Years - 99 YearsAllTata Memorial Hospital
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In plain words

What the trial is, and whether it could suit you

A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.

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๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ 500 cells/mm3; * Platelets โ‰ฅ 50,000 cells/mm3; * Hemoglobin โ‰ฅ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb โ‰ฅ 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: 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
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What it tests

  • Local Consolidative Radiation Therapy
  • TKI
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Where

1 site
Tata Memorial Hospital
Mumbai, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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