Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Small cell lung cancer (SCLC) is a kind of disease with high degree of malignancy and poor prognosis.Based on the effectiveness of systemic chemotherapy, the treatment of primary lesions and whole brain radiotherapy can bring survival benefits to patients with extensive stage small cell lung cancer.Patients with liver metastasis have a worse prognosis than those with other organ metastases.Local radiotherapy for patients with liver metastasis may have a better prognosis.However, clinical data of the safety and efficacy of whole liver radiotherapy for liver metastasis are still lacking.The purpose of this prospective study is to evaluate the safety, efficacy, and tolerability of liver metastatic radiotherapy in small cell lung cancer (SCLC).

Official Title
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A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.

Conditions
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Radiotherapy; Complications

Intervention / Treatment
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* Radiation: Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherpy will be performed to thoracic and liver metastasis.<br>Radiotherapy for liver metastases and thoracic will be performed in paticipants with liver metastasis who achieved CR or PR after chemotherapy. | Radiation: Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.<br>* Intensity modulated radiotherapy will be performed to liver metastasis and thoracic SCLC patients who achieved CR or PR after chemotherapy .<br>|
| No Intervention: Radiotherpy will be performed to thoracic.<br>Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrahepatic progression -free survial(Intrahepatic-PFS) | Intrahepatic progression -free survial is defined as the duration of time from start of treatment to time of progression of hepatic metastasis. | UP to 5years | 
| Overall survival (OS) | Overall survival is defined as the time interval from date of diagnosis to date of death from any cause. | UP to 5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) | PFS is defined as the duration of time from start of treatment to time of progression or death,whichever occurs first. | UP to 5years | 
| Adverse events(toxicities) | The descriptions and grading scales found in the revised Common Terminology Criteria for Adverse Events(CTCAE 4.0) will be utilized for all toxicity reporting. | UP to 5years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy;liver metastases;Small cell lung cancer;