Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer
Recruiting · NCT05150145 · Interventional (participants receive a specific treatment) · Lead sponsor: Guizhou Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
What this trial is about
The aim of this randomized study is to investigate local tumor control,survival outcomes and complications on patients of liver metastasis in small cell lung cancer.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Informed consent (radiation, medication) before treatment;
- Age 18 to 70 years old,regardless of gender;
- Initial SCLC confirmed by histopathological or cytological examination;
- Metastatic lesions in the distant area: included liver metastasis；
- Physical status score ECOG: 0 to 2；
- The expected survival time is more than 3 months;
- Bone marrow function:hemoglobin(HGB)\>90g/L,platelet(PLT)\>100×109/L,neutrophil cell(WBC)\>1.5×109/L(\*normal value);
- Liver function:alanine aminotransferase(ALT) and aspertate aminotransferase(AST)\<1.5 times of the upper limit of normal(ULN);Total bilirubin \<1.5ULN;
- Renal function:Serum creatinine was lower than 1.5ULN,and the endogenous creatinine clearance rate(Ccr) is higher than 55mL/min;
- Initial treatment (previously did not receive any thoracic radiotherapy or surgery).
Exclusion criteria
- patients with history of mental illness;
- patients combined with other malignancies;
- Active period of disease caused by bacteria, fungi or viruses; and these severe infection requiring intravenous antibiotics,antifungal or antiviral therapy;
- Patients with serious cardiovascular disease ,including uncontrolled hypertension, unstable angina,history of myocardial infarction within the past 12 months,and severe arrhythmias.
- Patients with poorly controlled diabetes who are judged to be unfit for chemotherapy by doctors.
- History of hepatitis and cirrhosisi ;
- pregnant, lactating patients;
- Patients with poor compliance；
- Researchers believe that it is not appropriate to participate in this test.
Where it is running
1 location listed.
- The affiliated hospital of Guizhou medical university - Guiyang, Guizhou, China