Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

NCT ID: NCT05150145

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2026-03-01

Brief Summary

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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

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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).

Conditions

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Radiotherapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 .

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guizhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shengfa Su, doctor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Guizhou Medical University

Locations

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The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengfa Su, PhD,MD

Role: CONTACT

86-13608550432

Facility Contacts

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Shengfa Su, PhD,MD

Role: primary

86-13608550432

Other Identifiers

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E-SCLC-liver001

Identifier Type: -

Identifier Source: org_study_id

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