Radiotherapy; ComplicationsNCT05150145
Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer
A study testing Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy. in people with Radiotherapy; Complications, run by Guizhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiotherapy; Complications
- What is being tested?
- Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2021to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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 ;
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- pregnant, lactating patients;
- Patients with poor compliance；
- Researchers believe that it is not appropriate to participate in this test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The affiliated hospital of Guizhou medical university
Guiyang, Guizhou, 550004
Shengfa Su, PhD,MD, 86-13608550432, sushengfa2005@163.com
About this study
Official title: A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.
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.
Read the 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).
- Conditions
- Radiotherapy; Complications
- Being tested
- Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.
- Keywords
- Radiotherapy;liver metastases;Small cell lung cancer;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy.Radiation
Intensity modulated radiotherapy will be performed to liver metastasis and thoracic SCLC patients who achieved CR or PR after chemotherapy .
| Study group | Role | What they receive |
|---|---|---|
| Radiotherpy will be performed to thoracic and liver metastasis. | Experimental | Radiotherapy for liver metastases and thoracic will be performed in paticipants with liver metastasis who achieved CR or PR after chemotherapy. Receives: Radiation: Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy. |
| Radiotherpy will be performed to thoracic. | No intervention | Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: UP to 5years
Overall survival (OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Measured: UP to 5years
Secondary outcomes (2)
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.
Measured: UP to 5years
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.
Measured: UP to 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start30 Apr 2021
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shengfa Su, doctor, Principal investigator, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150145
- Sponsor's protocol ID
- E-SCLC-liver001
- Status last verified
- Jun 2025
- First submitted
- 28 Nov 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT05150145
- Acronym / sponsor ID
- E-SCLC-liver001
- Conditions
- Radiotherapy; Complications
- Keywords
- Radiotherapy;liver metastases;Small cell lung cancer;
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherpy will be performed to thoracic and liver metastasis. | Experimental | Radiation: 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. |
| Radiotherpy will be performed to thoracic. | No intervention | –Radiotherapy performed only on the thoracic after chemotherapy of paticipants with liver metastasis who achieved CR or PR. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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；
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 . | Radiation | Radiotherpy will be performed to thoracic and liver metastasis. |
Primary outcome
Intrahepatic progression -free survial(Intrahepatic-PFS)
Time frame: 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.
Overall survival (OS)
Time frame: UP to 5years
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
2 secondary outcomes
Progression-free survival(PFS)
Time frame: UP to 5years
Adverse events(toxicities)
Time frame: UP to 5years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shengfa Su, doctor principal investigator
The Affiliated Hospital Of Guizhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherpy will be performed to thoracic and liver metastasis after chemotherapy. in people with Radiotherapy; Complications, run by Guizhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengfa Su, PhD,MD (86-13608550432, sushengfa2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic progression -free survial(Intrahepatic-PFS) (time frame: UP to 5years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.