Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

NCT05150145 | Recruiting

• 1 other identifier: E-SCLC-liver001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiotherapy; Complications

Keywords

Radiotherapy;liver metastases;Small cell lung cancer;

Outcome Measures

Primary Outcomes (2)

• Intrahepatic progression -free survial(Intrahepatic-PFS)

  Intrahepatic progression -free survial is defined as the duration of time from start of treatment to time of progression of hepatic metastasis.

  UP to 5years

• Overall survival (OS)

  Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.

  UP to 5years

Secondary Outcomes (2)

• Progression-free survival(PFS)

  UP to 5years

• Adverse events(toxicities)

  UP to 5years

Study Arms (2)

Radiotherpy will be performed to thoracic and liver metastasis.

EXPERIMENTAL

Radiotherapy for liver metastases and thoracic will be performed in paticipants with liver metastasis who achieved CR or PR after chemotherapy.

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

Radiotherpy will be performed to thoracic.

NO INTERVENTION

Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR.

Interventions

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 .

Radiotherpy will be performed to thoracic and liver metastasis.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guizhou Medical University: lead

Study Sites (1)

The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, 550004, China

RECRUITING

Study Officials

• Shengfa Su, doctor

  Affiliated Hospital of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengfa Su, PhD,MD

CONTACT

86-13608550432; sushengfa2005@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 8, 2021
• Study Start: April 30, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)