Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial
Standard of care maintenance therapy alone (standard arm) versus local consolidative radiation therapy and standard of care maintenance therapy (Experimental arm)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site
Standard maintenance therapy/Observation
Tata Memorial Hospital, Parel
Mumbai, Maharashtra, India
RECRUITINGOverall survival (OS)
Overall survival is defined as the duration between the date of randomization to the date of death due to any cause or the date of last follow-up, whichever is earlier.
Time frame: Upto 2 years
Progression free survival (PFS )
Progression free survival is defined as the duration between the date of randomization to the date of first documented progression or death due to any cause or date of last follow-up, whichever is earlier.
Time frame: Upto 2 years
Local control rates of treated sites
Local control rate will be defined as the absence of progressive disease at the treated sites
Time frame: Upto 2 years
New distant metastases
Time to onset of new distant metastases
Time frame: Upto 2 years
Health Related QOL using the EORTC-QLQ-C30 questionnaire
To evaluate patient reported outcomes between the two arms
Time frame: From randomization every 3 months till 2 years
Health Related QOL using the EORTC- LC13 questionnaire
To evaluate patient reported outcomes between the two arms
Time frame: From randomization every 3 months till 2 years
Response rates
To compare response rates between the two arms
Time frame: From randomization every 3 months upto 2 years
Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
At baseline and at subsequent follow up till 2 years
Time frame: Upto 2 years