CLINICAL TRIAL

Stereotactic Body Radiation Therapy (SBRT) for Small Cell Lung Carcinoma

Metastatic
Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether radiation treatment directed at liver metastases can improve responses to standard chemo-immunotherapy in people with extensive stage small cell lung cancer.

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About the trial for Small Cell Lung Carcinoma

Eligible Conditions
Small-cell Lung Cancer · Small Cell Lung Carcinoma · Lung Neoplasms

Treatment Groups

This trial involves 2 different treatments. Stereotactic Body Radiation Therapy (SBRT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Carboplatin
DRUG
Stereotactic Body Radiation Therapy (SBRT)
RADIATION
Atezolizumab
DRUG
Etoposide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Stereotactic Body Radiation Therapy (SBRT)
2010
Completed Phase 2
~590
Atezolizumab
FDA approved
Etoposide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
: Patients who have a history of receiving treatment for CNS metastases, but who have no symptoms of CNS metastases, are eligible for the study if they meet the following criteria: - They must have a history of CNS metastases show original
We will only consider metastases in the brain that are located in the supratentorial area or cerebellum, and not in the midbrain, pons, medulla, or spinal cord. show original
There was no evidence of any progression that happened between the time when the person finished treatment that targeted the central nervous system and when the screening radiographic study was done. show original
The Eastern Cooperative Oncology Group (ECOG) has defined two performance status categories for cancer patients: 0 or 1 show original
in SLE There is no need for corticosteroids to be taken as a form of therapy for any central nervous system-related diseases that may present in those who have SLE. show original
of surgery No radiation therapy within one week before or two weeks after surgery. show original
is an indication for radiation therapy ES-SCLC is a form of lung cancer that is confirmed through a histological or cytological test show original
If a patient has a new asymptomatic Central Nervous System (CNS) metastasis detected on a screening scan, that patient must receive radiation therapy and/or surgery for CNS metastases show original
Age≥ 18 years
No prior treatment for ES-SCLC
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Stereotactic Body Radiation Therapy (SBRT) will improve 1 primary outcome and 2 secondary outcomes in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Up to 6 months.

Progression Free Survival (PFS) Rate
UP TO 6 MONTHS
Progression free survival rate at 6 months will be measured to assess the efficacy of liver-directed SBRT when added to standard of care atezolizumab + chemotherapy. 6-month PFS rate will be defined as the proportion of patients that are progression free and alive at 6 months from the start of treatment.
UP TO 6 MONTHS
Overall Survival Rate
UP TO 2 YEARS
Overall survival (OS) will be defined as the time from treatment start to date of death or last follow up. Patients lost to follow-up at the cut-off date will be censored in the analysis.
UP TO 2 YEARS
Disease control rate (DCR)
UP TO 2 YEARS
Disease control rate (DCR) will be defined as the proportion of patients who have a partial (PR) or complete response (CR) or stable disease (SD) after beginning study treatment. Only patients who have received at least one cycle of therapy and have had their disease re-evaluated will be considered evaluable for response.
UP TO 2 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the chances of developing small cell lung carcinoma?

Overall, 25% of patients developed SCLC, however these risks did not differ significantly according to sex. The strongest risk factors were age at diagnosis (P<0.001), cigarette smoking (P=0.001), and squamous cell lung cancer (P=0.02). The other risk factors included alcohol consumption, ethnicity, and radiotherapy exposure.

Anonymous Patient Answer

What are the signs of small cell lung carcinoma?

The most common presenting symptoms include weakness and fatigue, but many patients present with unremarkable findings. The most important sign is the radiological imaging study of the chest which demonstrates the spread of the cancer. These studies should be performed by an experienced radiologist.

Anonymous Patient Answer

Is stereotactic body radiation therapy (sbrt) typically used in combination with any other treatments?

SBRT is commonly administered as part of multimodality treatments including surgery, chemotherapy, and (for NSCLC) radiotherapy. The optimal timing of SBRT delivery is yet to be established.

Anonymous Patient Answer

What is small cell lung carcinoma?

The incidence of SCC has been increasing rapidly in North America over the past 35 years. However, its exact etiology remains unknown. A number of factors such as smoking, immunosuppression, and exposure to asbestos might play a role. The role of radiotherapy in the management of SCT is not clear.

Anonymous Patient Answer

Have there been any new discoveries for treating small cell lung carcinoma?

There have not been any new discoveries for treating SCLC. Current treatments for SCLC include chemotherapy, radiation, surgery, targeted therapies, and immunotherapy. The use of these methods is limited to treating only some patients with SCLC. New techniques are being developed to treat SCLC and will likely be used in conjunction with current treatments. The use of these techniques will allow physicians to better treat patients with SCLC.

Anonymous Patient Answer

What is the average age someone gets small cell lung carcinoma?

The mean age of diagnosis for SCLC is 64 years old. Although the overall probability of survival has increased over the past 30 years, the 5-year survival rate remains around 33%. SCLC is more common in men than in women; however, this does not appear to be a significant factor when estimating prognosis. Over 90% of cases occur in non-smokers, suggesting that cigarette smoking is not a major risk factor for developing SCLC.

Anonymous Patient Answer

How quickly does small cell lung carcinoma spread?

The majority of SCLC tumors (46%) were limited to the primary site at diagnosis. About 12% of SCLC tumors metastasized to regional lymph nodes, and 14% of these nodal metastases were limited to the mediastinum. Only a small percentage of SCLC patients (5%) had distant metastasis. This analysis indicates that SCLC has a more locally aggressive behavior than NSCLC.

Anonymous Patient Answer

What is the primary cause of small cell lung carcinoma?

The data show this to be a rare disease. Patients should know that the risk factors for SCLC are much the same as those for non-SCLC, so let's not forget that smoking is a major suspect.

Anonymous Patient Answer

What does stereotactic body radiation therapy (sbrt) usually treat?

Sbrt is an effective treatment modality for metastatic and unresectable malignancies. The indications for sbrt are increasing as our understanding of its therapeutic efficacy increases. Sbrt is being increasingly utilized in the treatment of many solid tumors including breast cancer, non-muscle-invasive bladder cancer, and prostate cancer. Since sbrt uses less toxic and less costly options than other modalities such as external beam radiotherapy (EBRT), we are seeing more patients treated with sbrt in the United States. This article focuses on the use of sbrt in the management of metastatic disease of the brain, spine, liver, and lung.

Anonymous Patient Answer

Who should consider clinical trials for small cell lung carcinoma?

Patients who wish to participate in a clinical trial for SCLC must understand their role in the research process and must accept that they will not benefit from the procedure. Therefore, patients may not need to know the investigational plan before deciding whether to enroll in the trial. Additionally, most patients do not understand the possible benefits of participating in a clinical trial, including potential impact on survival and quality of life. Inclusion criteria should include a definition of "low-risk" rather than "high-risk" patients to avoid bias that may result from enrollment based solely on patient characteristics. The inclusion criteria for future trials should focus on high-risk patients excluded from previous trials because of prohibitive risks (e.g.

Anonymous Patient Answer

What causes small cell lung carcinoma?

In order to prevent [small cell lung cancer](https://www.withpower.com/clinical-trials/small-cell-lung-cancer) in lung cancer survivors, two strategies should be used; early detection and regular screening. In addition to early detection, the people who have smoking history are encouraged to quit smoking and monitor their lung cancer risk.

Anonymous Patient Answer
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