Comparing Prophylactic Cranial Irradiation to Observation in Stage IV Lung Cancer

Department of Oncology, Affiliated Hospital of Guizhou Medical University Affiliated Cancer Hospital of Guizhou Medical University

This study is testing if giving preventive radiation to the brain can help people with stage IV lung cancer avoid brain tumors and live better and longer compared to just monitoring their condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Guizhou Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guiyang, Guizhou)
• Trial ID: NCT06014450 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of prophylactic cranial irradiation (PCI) compared to observation in patients with stage IV non-small cell lung cancer (NSCLC) who do not have brain metastases. The study aims to determine whether PCI can reduce the incidence of brain metastases and improve overall survival and quality of life. Participants will be randomly assigned to receive either PCI or no PCI, with systematic imaging examinations scheduled to monitor their condition over time. The trial will include patients aged 18 to 80 with specific health criteria and will utilize advanced imaging techniques to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with confirmed stage IV NSCLC and no existing brain metastases.

Not a fit: Patients with pre-existing brain metastases or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of brain metastases in patients with stage IV NSCLC, potentially improving survival rates and quality of life.

How similar studies have performed: Previous studies have shown promising results for prophylactic cranial irradiation in similar patient populations, suggesting potential efficacy for this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with pathologically or cytologically confirmed NSCLC; patients with clinical stage IV and no brain metastases \[AJCC 8th edition\]; no previous treatment
* Age 18 \~ 80 years old, body condition score ECOG 0 \~ 2 or KPS≥70;
* No contraindications such as radiotherapy, EGFR-TKI, chemotherapy, or immunotherapy;
* IMRT is required for primary tumor radiotherapy. DT: 60-70Gy
* Metastases are treated with three-dimensional radiotherapy (IMRT/SRT/SBRT/VMAT, etc.) and large segmentation radiotherapy.
* The subject must have no major organ dysfunction or laboratory tests that meet the following requirements:
* Hematological tests such as liver and kidney function were in the normal range of laboratory standards;
* Cardiac function: electrocardiogram excluded organic arrhythmia;
* Pulmonary function test: FEV1\>50%, mild-moderate lung function limited.
* Signed informed consent before treatment (radiotherapy, chemotherapy, immunization, targeted drug therapy); The patient had good compliance with the treatment and follow-up received.

Exclusion Criteria:

* Patients with brain metastasis;
* Stage IV NSCLC patients with malignant pleural effusion, pericardial effusion and other serous effusion;
* Patients with extensive liver metastasis and intrapulmonary metastasis that have seriously affected liver and lung function;
* Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmia within the past 12 months; Have a clinically clear diagnosis of heart valve disease; The disease active phase of bacterial, fungal, or viral infection; Mental disorders; Severe impaired lung function;
* Pregnant or lactating patients;
* Patients with a history of active malignancy other than small cell lung cancer prior to enrollment; Non-melanoma skin basal cell carcinoma, in situ cervical cancer, cured early prostate cancer excepted;
* Patients with an allergy and known or suspected allergy to any investigational drug for which no alternative medicine is available;
* Patients with poor compliance;
* Researchers consider it inappropriate to participate in this experiment.

Where this trial is running

Guiyang, Guizhou

• Guizhou Cancer Hospital — Guiyang, Guizhou, China (Recruiting)

Study contacts

• Study coordinator: Bing Lu, Bachelor

Conditions Prophylactic Cranial Irradiation, Cumulative Incidence of Brain Metastases; stage IV non-small cell lung cancer; PCI