Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

Not Applicable

• Conditions: Radiotherapy; Complications
• Interventions: Radiation: Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.

• Registration Number: NCT05150145
• Lead Sponsor: Guizhou Medical University

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.

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 Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-11-28
• Study First Submitted QC: 2021-11-28
• Last Update Submitted: 2021-11-28
• Study Start: 2021-12-01
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08
• Primary Completion: 2023-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	UP to 5years	Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Intrahepatic progression -free survial(Intrahepatic-PFS)	UP to 5years	Intrahepatic progression -free survial is defined as the duration of time from start of treatment to time of progression of hepatic metastasis.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The affiliated hospital of Guizhou medical university; 🇨🇳 Guiyang, Guizhou, China