CTRI/2019/11/021872RecruitingPhase 2
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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Tata Memorial Hospital
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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:
- •Ã¢â?¬Â¢Absolute neutrophil count (ANC) ââ?°Â¥ 500 cells/mm3;
- •Ã¢â?¬Â¢Platelets ââ?°Â¥ 50,000 cells/mm3;
- •Ã¢â?¬Â¢Hemoglobin ââ?°Â¥ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb ââ?°Â¥ 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:
- •Ã¢â?¬Â¢Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- •Ã¢â?¬Â¢Transmural myocardial infarction within the last 6 months;
- •Ã¢â?¬Â¢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
Investigators
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