Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

Radiotherapy; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05150145
• Other study ID #: E-SCLC-liver001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: July 2021
• Source: Guizhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm Metastasis
• Radiotherapy; Complications
• Small Cell Lung Carcinoma

Intervention

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 .

Locations

Country	Name	City	State
China	The affiliated hospital of Guizhou medical university	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Guizhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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