Actively Recruiting
Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC
Led by Tata Memorial Hospital · Updated on 2025-09-10
190
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- ECOG performance status between 0 and 2
- Pathologically confirmed diagnosis of non-small cell lung cancer
- 1 to 5 metastatic sites excluding the primary tumor and regional lymph nodes (no more than 3 lesions in one organ)
- Completed 4 to 6 cycles of standard systemic therapy without disease progression
- Suitable for definitive therapy to the primary tumor
- All oligometastases visible on imaging and suitable for ablative radiation doses
- Previous ablative radiation, surgery, or RFA allowed if total metastatic sites remain 5 or fewer
- Palliative radiation or RFA for symptomatic bone metastases allowed if treated site is controlled
- Surgical decompression or stabilization followed by palliative radiation for bone metastases allowed if controlled and fewer than 5 metastatic sites
- Adequate organ function including bone marrow function with ANC ≥ 500 cells/mm3, platelets ≥ 50,000 cells/mm3, hemoglobin ≥ 8.0 g/dl
- Negative pregnancy test for females of child-bearing potential within 14 days prior to registration
- Willingness to provide written informed consent and comply with follow-up schedule
You will not qualify if you...
- Progressive disease after initial standard systemic therapy
- Presence of oncogene driver mutations
- More than 5 metastatic sites
- Any metastatic lesion larger than 5 cm
- More than three metastatic lesions in a single organ
- Not suitable for definitive radiation therapy to primary tumor
- Not suitable for ablative radiation therapy to metastatic sites
- Malignant peritoneal disease
- Malignant pleural effusion
- Leptomeningeal disease
- Brain metastases located in the brain stem
- Evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI
- Severe active co-morbidities including unstable angina, congestive heart failure, recent myocardial infarction, or severe respiratory illness requiring hospitalization
- Prior thoracic radiation therapy
- History of other malignancy within last 3 years
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tata Memorial Hospital, Parel
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
D
Dr. Anil Tibdewal
CONTACT
D
Dr. Jai Prakash Agarwal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here