Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer
NCT ID: NCT05150145
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2021-04-30
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiotherpy will be performed to thoracic and liver metastasis.
Radiotherapy for liver metastases and thoracic will be performed in paticipants with liver metastasis who achieved CR or PR 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 .
Radiotherpy will be performed to thoracic.
Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR.
No interventions assigned to this group
Interventions
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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 .
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Guizhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Shengfa Su, doctor
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Guizhou Medical University
Locations
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The affiliated hospital of Guizhou medical university
Guiyang, Guizhou, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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E-SCLC-liver001
Identifier Type: -
Identifier Source: org_study_id
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