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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI
TKI
Tata Memorial Hospital
Mumbai, Maharashtra, India
RECRUITINGProgression Free Survival (PFS)
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.
Time frame: Upto 2 years
Overall survival (OS)
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.
Time frame: Upto 2 years
Local control rates
Local control will be defined as the lack of progressive disease at the treated sites (complete response, partial response and stable disease).
Time frame: Upto 2 years
Health Related Quality of Life using the EORTC-QLQ-C30 questionnaire
Quality of life will be assessed for each arm
Time frame: From time of randomization to time of death or up to 24 months
Health Related Quality of Life using the EORTC-LC13 questionnaire
Quality of life will be assessed for each arm
Time frame: From time of randomization to time of death or up to 24 months
Toxicities using CTC v5.0 (radiotherapy related)
Toxicity will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years
Time frame: From time of Randomization to time of death or up to 24 months
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