Radiotherapy or Observation of 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.

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.

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy; Complications
• Intervention / Treatment: Radiation: Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.

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).

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shengfa Su, PhD,MD; Phone Number: 86-13608550432; Email: sushengfa2005@163.com

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Recruiting
      • The Affiliated Hospital of Guizhou Medical University
      • Contact: Shengfa Su, PhD,MD; Phone Number: 86-13608550432; Email: sushengfa2005@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherpy will be performed to thoracic and liver metastasis.; 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.; Intensity modulated radiotherapy will be performed to liver metastasis and thoracic SCLC patients who achieved CR or PR after chemotherapy .
No Intervention: Radiotherpy will be performed to thoracic.; Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival(PFS)	PFS is defined as the duration of time from start of treatment to time of progression or death,whichever occurs first.	UP to 5years
Adverse events(toxicities)	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.	UP to 5years

Collaborators and Investigators

• Sponsor: Guizhou Medical University
• Investigators: Principal Investigator: Shengfa Su, doctor, Affiliated Hospital of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 28, 2021
• First Submitted That Met QC Criteria: November 28, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 22, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Radiotherapy;liver metastases;Small cell lung cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Small Cell Lung Carcinoma
• Other Study ID Numbers: E-SCLC-liver001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No