RecruitingPhase 3NCT05278052

Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC

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


Sponsor

Tata Memorial Hospital

Enrollment

190 participants

Start Date

Apr 20, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether adding targeted radiation therapy to standard maintenance treatment can improve outcomes for people with non-small cell lung cancer (NSCLC) that has spread to only a few spots in the body (called oligometastatic disease). After completing several cycles of standard systemic therapy without the cancer worsening, patients are randomly assigned to maintenance therapy alone or maintenance therapy plus targeted, high-dose radiation to all remaining disease sites. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with NSCLC that has spread to 1–5 sites in the body - You completed 4–6 cycles of standard systemic therapy without the cancer progressing - All spread sites are visible on imaging and suitable for high-dose radiation **You may NOT be eligible if...** - Your cancer progressed during initial therapy - Your cancer has a known driver gene mutation (such as EGFR or ALK) - You have more than 5 spread sites, or more than 3 in a single organ, or any lesion larger than 5 cm - You have cancer in the lining of the brain, spinal cord compression, or a serious heart or lung condition - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONLocal consolidative radiation therapy

Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site

DRUGStandard maintenance therapy as decided by the treating medical oncologist

Standard maintenance therapy/Observation


Locations(1)

Tata Memorial Hospital, Parel

Mumbai, Maharashtra, India

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NCT05278052


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