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NCT Number: NCT05150145

Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, 550004, China

Location status: Recruiting

Location contact

Shengfa Su, PhD,MD

CONTACT

[email protected]

86-13608550432

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.

Radiation

Intensity modulated radiotherapy will be performed to liver metastasis and thoracic SCLC patients who achieved CR or PR after chemotherapy .

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Progression-free survival(PFS)

    Time frame: UP to 5years

    PFS is defined as the duration of time from start of treatment to time of progression or death,whichever occurs first.

  2. Adverse events(toxicities)

    Time frame: UP to 5years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shengfa Su, PhD,MD

CONTACT

[email protected]

86-13608550432

Sponsors and collaborators

Lead sponsor

Guizhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2021
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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