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Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

Primary Purpose

Radiotherapy; Complications

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
Sponsored by
Guizhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiotherapy; Complications focused on measuring Radiotherapy;liver metastases;Small cell lung cancer;

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The affiliated hospital of Guizhou medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Radiotherpy will be performed to thoracic and liver metastasis.

Radiotherpy will be performed to thoracic.

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Overall survival (OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 28, 2021
Last Updated
November 28, 2021
Sponsor
Guizhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05150145
Brief Title
Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer
Official Title
A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy; Complications
Keywords
Radiotherapy;liver metastases;Small cell lung cancer;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherpy will be performed to thoracic and liver metastasis.
Arm Type
Experimental
Arm Description
Radiotherapy for liver metastases and thoracic will be performed in paticipants with liver metastasis who achieved CR or PR after chemotherapy.
Arm Title
Radiotherpy will be performed to thoracic.
Arm Type
No Intervention
Arm Description
Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR.
Intervention Type
Radiation
Intervention Name(s)
Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
Intervention Description
Intensity modulated radiotherapy will be performed to liver metastasis and thoracic SCLC patients who achieved CR or PR after chemotherapy .
Primary Outcome Measure Information:
Title
Intrahepatic progression -free survial(Intrahepatic-PFS)
Description
Intrahepatic progression -free survial is defined as the duration of time from start of treatment to time of progression of hepatic metastasis.
Time Frame
UP to 5years
Title
Overall survival (OS)
Description
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Time Frame
UP to 5years
Secondary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
PFS is defined as the duration of time from start of treatment to time of progression or death,whichever occurs first.
Time Frame
UP to 5years
Title
Adverse events(toxicities)
Description
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.
Time Frame
UP to 5years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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). Exclusion Criteria: patients with history of mental illness; patients combined with other malignancies; Active period of disease caused by bacteria, fungi or viruses; and these severe infection requiring intravenous antibiotics,antifungal or antiviral therapy; Patients with serious cardiovascular disease ,including uncontrolled hypertension, unstable angina,history of myocardial infarction within the past 12 months,and severe arrhythmias. Patients with poorly controlled diabetes who are judged to be unfit for chemotherapy by doctors. History of hepatitis and cirrhosisi ; pregnant, lactating patients; Patients with poor compliance； Researchers believe that it is not appropriate to participate in this test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengfa Su, doctor
Organizational Affiliation
Affiliated Hospital of Guizhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The affiliated hospital of Guizhou medical university
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

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