Oligometastatic Disease, Non-small Cell Lung Cancer, Driver Mutation
Conditions
Keywords
Oligometastatic NSCLC, Driver mutation, TKI, Local consolidative therapy, SABR, Oligometastases
Brief summary
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.
Detailed description
Randomization Arms: Eligible patients will be randomized in 1:1 ratio to TKI alone or TKI + LCRT. This will be an intention to treat randomized study. Arm 1: Continuation of TKI therapy alone Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to loc0-regional disease and 1-5 oligometastatic sites
Interventions
Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI
DRUGTKI
TKI
Sponsors
Tata Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, parallel-group RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
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 | Description |
|---|---|---|
| Progression Free Survival (PFS) | Upto 2 years | Progression Free Survival will be defined as the time from the date of randomization until the date of disease recurrence or progression is documented, or until death in the absence of recurrence, whichever is earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Upto 2 years | Overall survival will be defined as the time from randomization until the date of death from any cause in the presence or absence of recurrence. |
| Local control rates | Upto 2 years | Local control will be defined as the lack of progressive disease at the treated sites (complete response, partial response and stable disease). |
| Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire | From time of randomization to time of death or up to 24 months | Quality of life will be assessed for each arm |
| Health Related Quality of Life using the EORTC-LC13 questionnaire | From time of randomization to time of death or up to 24 months | Quality of life will be assessed for each arm |
| Toxicities using CTC v5.0 (radiotherapy related) | From time of Randomization to time of death or up to 24 months | Toxicity will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years |
Countries
India
Contacts
Primary ContactDr. Anil Tibdewal, MD
Backup ContactDr. Jai Prakash Agarwal, MD
Outcome results
None listed