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Recruiting NCT05150145

Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

No phase Interventional Radiotherapy; Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy..
Who it may be relevant to
Registry conditions: Radiotherapy; Complications. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Intrahepatic progression -free survial(Intrahepatic-PFS) [Time frame: UP to 5years]
  • Overall survival (OS) [Time frame: UP to 5years]
Secondary outcome measures (2)
  • Progression-free survival(PFS) [Time frame: UP to 5years]
  • Adverse events(toxicities) [Time frame: UP to 5years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The affiliated hospital of Guizhou medical university — Guiyang

Identifiers

NCT: NCT05150145 · E-SCLC-liver001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗