Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.: Intensity modulated radiotherapy will be performed to liver metastasis and thoracic SCLC patients who achieved CR or PR after chemotherapy .
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Intrahepatic progression -free survial(Intrahepatic-PFS) — UP to 5years Intrahepatic progression -free survial is defined as the duration of time from start of treatment to time of progression of hepatic metastasis.
Overall survival (OS) — UP to 5years Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Trial sites (1)
Facility
City
Region
Status
The affiliated hospital of Guizhou medical university
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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