Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer
ConditionRadiotherapy; Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuizhou Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
RadiationIntensity modulated radiotherapy will be performed to liver metastasis and thoracic SCLC patients who achieved CR or PR after chemotherapy .
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Radiotherpy will be performed to thoracic and liver metastasis.Experimental treatment 1 intervention
Group B: Radiotherpy will be performed to thoracic.No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
UP to 5years2
Overall survival (OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Time frame
UP to 5yearsSecondary outcomes
1
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.
Time frame
UP to 5years2
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.
Time frame
UP to 5yearsSponsors and contacts
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Source ClinicalTrials.gov