Actively Recruiting
Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-30
104
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are: Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy. Participants will: Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.
CONDITIONS
Official Title
Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically and/or cytologically confirmed stage IV metastatic non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Prior first-line chemotherapy with clinical benefit lasting at least 3 months
- Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with immune checkpoint inhibitors (ICI)
- Driver gene-positive NSCLC patients (e.g., EGFR mutation or ALK fusion positive) allowed if oligo-progression occurred during first-line chemotherapy combined with bevacizumab with or without ICI after tyrosine kinase inhibitor (TKI) therapy failure
- Up to 5 extracranial progressive sites assessed by RECIST v1.1 criteria and PET/CT, all suitable for SBRT treatment
- Progressive lymph node lesions counted by region, with each lymph node region amenable to concurrent SBRT counted as one progressive site
- Intracranial progressive lesions and symptomatic lesions treated with palliative radiotherapy or local therapy prior to enrollment and not counted as oligo-progressive sites
- Expected survival time greater than 3 months
- Completed comprehensive examination within 28 days prior to enrollment and complete blood count/differential within 15 days showing normal organ and bone marrow function
- Negative serum or urine pregnancy test in females of childbearing potential within 14 days prior to enrollment
- Willing to provide written informed consent and adhere to follow-up schedule
You will not qualify if you...
- Currently participating in another interventional clinical study or treated with investigational drugs/devices affecting this study within 4 weeks prior to treatment
- Pregnant or breastfeeding women
- Progressive sites unsuitable for SBRT treatment as determined by radiotherapy specialists
- Presence of untreated intracranial metastases or symptomatic progressive sites
- History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years
- Serious active comorbidities interfering with study treatment
- History or evidence of disease, abnormal laboratory values, or other conditions making participation inappropriate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
F
Fuming Qiu, PhD
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