Radiotherapy versus observation for 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.

This trial tests whether giving radiotherapy to the liver after chemotherapy helps people with small cell lung cancer that has spread to the liver live longer and control tumors better than observation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guizhou Medical University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guiyang, Guizhou)
• Trial ID: NCT05150145 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–70 with confirmed small cell lung cancer and liver metastases, ECOG performance status 0–2, adequate organ function, and no prior thoracic radiotherapy or surgery are ideal candidates.

Not a fit: Patients with poor performance status, other active malignancies, significant organ dysfunction, a history of mental illness precluding consent, or who cannot tolerate radiotherapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, adding liver radiotherapy could improve local tumor control and potentially extend survival for patients with SCLC and liver metastases.

How similar studies have performed: Local radiotherapy has benefited liver metastases in other cancers, but whole-liver radiotherapy specifically for small cell lung cancer remains largely untested.

Eligibility criteria

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 this trial is running

Guiyang, Guizhou

• 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

Conditions Radiotherapy; Complications; liver metastases; Small cell lung cancer