A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiotherapy; Complications
- Sponsor
- Guizhou Medical University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: UP to 5years
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Intrahepatic progression -free survial(Intrahepatic-PFS)
Time Frame: 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.
Secondary Outcomes
- Progression-free survival(PFS)(UP to 5years)
- Adverse events(toxicities)(UP to 5years)