Radiotherapy versus observation for liver metastases in small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized study comparing liver (and thoracic) radiotherapy to observation in patients with small cell lung cancer who have liver metastases after systemic chemotherapy. Eligible participants are adults 18–70 with histologically or cytologically confirmed SCLC, ECOG 0–2, adequate blood, liver and kidney function, and no prior thoracic radiotherapy or surgery. The main outcomes are local tumor control, survival outcomes, and treatment-related complications, with safety and tolerability monitored during follow-up. The single-center trial is led by Guizhou Medical University and aims to fill a gap in evidence on whole-liver radiotherapy in SCLC.

Why it matters

Who can join: the full rules

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.

Where it's running

• The affiliated hospital of Guizhou medical university
  Guiyang, Guizhou, China Recruiting

Study contacts

• Principal investigator: Shengfa Su, doctor — The Affiliated Hospital Of Guizhou Medical University
• Study coordinator: Shengfa Su, PhD,MD
• Email: sushengfa2005@163.com
• Phone: 86-13608550432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.