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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
The affiliated hospital of Guizhou medical university
RECRUITING
Guiyang
Contact Information
Primary
Shengfa Su, PhD,MD
sushengfa2005@163.com
86-13608550432
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 66
Treatments
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.
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.
Sponsors
Leads: Guizhou Medical University

This content was sourced from clinicaltrials.gov