Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

Launched by GUIZHOU MEDICAL UNIVERSITY · Nov 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether giving radiotherapy (a type of targeted radiation treatment) to liver tumors can help control cancer and improve survival in people with small cell lung cancer that has spread to the liver. Researchers want to compare the effects of radiotherapy to simply watching the tumors without immediate treatment, to see which approach works better and what side effects might occur.

People who may join this study are adults between 18 and 70 years old who have been diagnosed with small cell lung cancer that has spread to the liver. They need to be generally healthy enough to receive treatment, with good blood counts, liver and kidney function, and an expected life of at least three months. Participants should not have other serious health problems like active infections, heart disease, or other cancers, and must not be pregnant or breastfeeding. If you join, you will either receive radiotherapy aimed at the liver tumors or be closely monitored without radiotherapy, and your health and cancer will be regularly checked to see how well the treatments work and if there are any side effects. This study is currently recruiting patients.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Informed consent (radiation, medication) before treatment;
• • 2. Age 18 to 70 years old,regardless of gender;
• • 3. Initial SCLC confirmed by histopathological or cytological examination;
• • 4. Metastatic lesions in the distant area: included liver metastasis；
• • 5. Physical status score ECOG: 0 to 2；
• • 6. The expected survival time is more than 3 months;
• • 7. Bone marrow function:hemoglobin(HGB)\>90g/L,platelet(PLT)\>100×109/L,neutrophil cell(WBC)\>1.5×109/L(\*normal value);
• • 8. Liver function:alanine aminotransferase(ALT) and aspertate aminotransferase(AST)\<1.5 times of the upper limit of normal(ULN);Total bilirubin \<1.5ULN;
• • 9. Renal function:Serum creatinine was lower than 1.5ULN,and the endogenous creatinine clearance rate(Ccr) is higher than 55mL/min;
• • 10. Initial treatment (previously did not receive any thoracic radiotherapy or surgery).
• Exclusion Criteria:
• • 1. patients with history of mental illness;
• • 2. patients combined with other malignancies;
• • 3. Active period of disease caused by bacteria, fungi or viruses; and these severe infection requiring intravenous antibiotics,antifungal or antiviral therapy;
• • 4. Patients with serious cardiovascular disease ,including uncontrolled hypertension, unstable angina,history of myocardial infarction within the past 12 months,and severe arrhythmias.
• • 5. Patients with poorly controlled diabetes who are judged to be unfit for chemotherapy by doctors.
• • 6. History of hepatitis and cirrhosisi ;
• • 7. pregnant, lactating patients;
• • 8. Patients with poor compliance；
• • 9. Researchers believe that it is not appropriate to participate in this test.