Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Лучевая терапия 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 .

Первичные конечные точки

• Intrahepatic progression -free survial(Intrahepatic-PFS) [Срок оценки: UP to 5years]
• Overall survival (OS) [Срок оценки: UP to 5years]

Вторичные конечные точки (2)

• Progression-free survival(PFS) [Срок оценки: UP to 5years]
• Adverse events(toxicities) [Срок оценки: UP to 5years]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The affiliated hospital of Guizhou medical university — Guiyang

Идентификаторы

NCT: NCT05150145 · E-SCLC-liver001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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