RecruitingNot ApplicableNCT05150145
Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer
A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.
Sponsor
Guizhou Medical University
Enrollment
66 participants
Start Date
Apr 30, 2021
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria10
- 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 Criteria9
- 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.
Interventions
RADIATIONRadiotherpy 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 .
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05150145
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