A Phase 3 interventional study of Local consolidative radiation therapy and Standard maintenance therapy as decided by the treating medical oncologist in Oligometastatic Disease and Metastatic Non Small Cell Lung Cancer, sponsored by Tata Memorial Hospital. Recruiting at 1 site in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Tata Memorial Hospital · Phase 3, Interventional, and Treatment
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)
6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.
This study's planned enrollment of 190 is above the median of 62 across 5,216 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Tata Memorial Hospital is the lead sponsor of 97 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate end organ function CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:
Exclusion Criteria:
Severe, active co-morbidity defined as follows:
Maintenance systemic therapy/ observation
Drug: Standard maintenance therapy as decided by the treating medical oncologist
Radiation therapy to all oligometastatic sites including primary loco-regional disease
Radiation: Local consolidative radiation therapy · Drug: Standard maintenance therapy as decided by the treating medical oncologist
Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site
Also known as: LCRT
Standard maintenance therapy/Observation
Overall 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)
At baseline and at subsequent follow up till 2 years
Time frame: Upto 2 years
Plan to share: No — Protocol manuscript is published and the results will be published in International peer-reviewed journal
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Carcinoma, Non-Small-Cell Lung→
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