Clinical trial · Interventional
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.
NCT05150145CI-TRIAL-00091397recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiotherapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherpy will be performed to thoracic and liver metastasis.
- description
- Radiotherapy for liver metastases and thoracic will be performed in paticipants with liver metastasis who achieved CR or PR after chemotherapy.
- interventionNames
- Radiation: Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
- type
- NO_INTERVENTION
- label
- Radiotherpy will be performed to thoracic.
- description
- Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR.
Primary outcomes (2)
- measure
- Intrahepatic progression -free survial(Intrahepatic-PFS)
- timeFrame
- UP to 5years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.