Status:
UNKNOWN
Prophylactic Cranial Irradiation Versus Observation in Stage IV NSCLC Randomized Controlled Clinical Study
Lead Sponsor:
Guizhou Medical University
Conditions:
Prophylactic Cranial Irradiation, Cumulative Incidence of Brain Metastases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Lung cancer has remained the leading cause of cancer-related deaths worldwide. An important and frequent cause of morbidity in this patient group is the development of brain metastases (BM). Lung canc...
Detailed Description
Group sample sizes of 72 in Group 1 and 72 in Group 2 achieve 90.140% power to detect a difference between the group proportions of 0.3100. The Group 2 proportion is 0.0700. The Group 1 proportion is ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06014450
Start Date
September 1 2023
End Date
August 1 2025
Last Update
August 28 2023
Active Locations (1)
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1
Guizhou Cancer Hospital
Guiyang, Guizhou, China, 550004