Actively Recruiting
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
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-30
104
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if Stereotactic Body Radiotherapy (SBRT) can improve outcomes for patients with oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The study focuses on whether adding SBRT to standard care enhances progression-free survival, overall survival, and quality of life. This is a phase 3, randomized, controlled, open-label, multi-center trial for patients with stage IV NSCLC who have limited progression after initial chemotherapy benefit lasting at least 3 months. Participants are randomly assigned to receive either SBRT combined with standard care or standard care alone. SBRT targets up to five extracranial progression sites with radiation doses tailored by the radiologist based on tumor size and location. Maintenance therapy during SBRT may include immune checkpoint inhibitors (ICI), bevacizumab, or single-agent chemotherapy. After progression unsuitable for SBRT, patients switch to second-line systemic therapy. The standard care group receives second-line therapy based on docetaxel or albumin-bound paclitaxel, possibly combined with immunotherapy or anti-vascular drugs. Palliative radiotherapy is allowed. During the study, participants undergo clinic visits for checkups and tests, keep symptom diaries, and complete quality of life questionnaires. Researchers monitor progression-free survival up to 18 months, overall survival up to 36 months, quality of life through survival follow-up, and safety of SBRT treatment. The study includes comprehensive examinations, imaging, blood tests, and pregnancy tests as part of screening and ongoing assessments.
CONDITIONS
Brief 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 or cytologically confirmed stage IV metastatic non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
- Prior first-line chemotherapy with clinical benefit lasting at least 3 months
- Driver gene-negative NSCLC with oligo-progression during first-line chemotherapy plus immune checkpoint inhibitors, or driver gene-positive NSCLC with oligo-progression during specified treatments after tyrosine kinase inhibitor failure
- Five or fewer extracranial progressive sites suitable for SBRT, visible on imaging and assessed by a radiotherapist
- Intracranial progressive or symptomatic lesions may have had prior palliative radiotherapy and are not counted in oligo-progressive sites
- Expected survival time greater than 3 months
- Completed comprehensive examination within 28 days prior to enrollment and normal blood counts within 15 days
- Negative pregnancy test in females of childbearing potential within 14 days prior to enrollment
- Willingness to provide informed consent and comply with follow-up schedule
You will not qualify if you...
- Current participation in another interventional clinical study or prior investigational treatment within 4 weeks before first treatment
- Pregnant or breastfeeding women
- Progressive sites unsuitable for SBRT treatment as assessed by specialists
- Untreated intracranial metastases or symptomatic progressive sites
- History of other malignancies within 3 years or untreated primary malignancy
- Serious active medical conditions interfering with study treatment
- Any condition or abnormal test results that may interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - SBRT treatment duration varies based on radiation doses, typically over 3 to 10 fractions; systemic therapy duration depends on disease progression
Participants receive either stereotactic body radiotherapy (SBRT) to progressive sites along with maintenance therapy, or second-line systemic therapy based on docetaxel or albumin-paclitaxel with optional immunotherapy or anti-vascular drugs.
Multiple visits for SBRT sessions and maintenance therapy or regular visits for systemic therapy as determined by the treatment plan
Duration - Up to 36 months
After treatment, participants are monitored for progression-free survival, overall survival, quality of life, and safety outcomes up to 36 months.
Periodic visits for evaluations and assessments during follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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