RecruitingPhase 3NCT06523673

Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer

Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

104 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding stereotactic body radiotherapy (SBRT) — a precise, high-dose form of radiation — to ongoing chemotherapy plus immunotherapy can help patients with advanced non-small cell lung cancer (NSCLC) whose cancer is progressing in only a small number of spots (called "oligo-progression"). The idea is that treating those specific progression sites may extend the benefit of the existing treatment. **You may be eligible if...** - You are 18 or older - You have confirmed stage IV non-small cell lung cancer - You previously benefited from first-line chemotherapy for at least 3 months - Your cancer is now progressing in 5 or fewer sites, all outside the brain, that are suitable for SBRT - You have adequate overall health, organ function, and blood counts **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have untreated brain metastases causing symptoms - You have had another cancer in the past 3 years (other than certain skin cancers) - Your progression sites cannot be safely treated with SBRT - You are currently in another interventional trial that could interfere with this study 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONStereotactic Body Radiotherapy

The dose of radiation therapy is determined by the radiologist based on the clinical parameters of the lesion, including tumor size and location. In most cases, radiotherapy fractionation regimens range from 27-30 Gy/3 Fractions or 30-50 Gy/5 Fractions, and appropriate radiotherapy doses covering 27-70 Gy/3-10 Fractions can also be selected by the radiologist based on radiation limitations of neighboring endangered organs.

DRUGsecond-line systemic therapy

a second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen


Locations(1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06523673


Related Trials