Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients in this arm will continue to receive standard treatment of TKI alone

Patients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI

Local consolidative radiation therapy to loco-regional disease and all Oligometastatic sites in addition to TKI

Local Consolidative Radiation Therapy

Dr. Anil Tibdewal, MD

Dr. Jai Prakash Agarwal, MD

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

Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

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

Protocol manuscript is published and the results will be published in International peer-reviewed journal

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.

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 will be defined as the lack of progressive disease at the treated sites (complete response, partial response and stable disease).

Quality of life will be assessed for each arm

Toxicity will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC	NCT05277844	Oligometastatic... Non-small Cell ... Driver Mutation	Local Consolida... TKI	18 Years - 99 Years	Tata Memorial Hospital
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC	NCT05277844	Oligometastatic... Non-small Cell ... Driver Mutation	Local Consolida... TKI	18 Years - 99 Years	Tata Memorial Hospital

Spots Global Cancer Trial Database for oligometastatic nsclc