CLINICAL TRIAL

Stereotactic Radiosurgery for Small Cell Lung Carcinoma

Metastatic
Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether stereotactic radiosurgery may help patients with small cell lung cancer avoid nervous system side effects caused by whole brain radiation therapy.

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About the trial for Small Cell Lung Carcinoma

Eligible Conditions
Brain Neoplasms · Stage IV Lung Cancer AJCC v8 · Metastatic Malignant Neoplasm in the Brain · Carcinoma, Small Cell · Lung Neoplasms · Metastatic Lung Small Cell Carcinoma · Stage IVB Lung Cancer AJCC v8 · Neoplasms · Small Cell Lung Carcinoma · Stage IVA Lung Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Stereotactic Radiosurgery 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.
Stereotactic Radiosurgery
RADIATION
Questionnaire Administration
OTHER
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
Stereotactic Radiosurgery
2016
Completed Phase 2
~170

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The treating physician will determine the patient's ECOG performance status. show original
Patients must be eligible to have all lesions treated with stereotactic radiosurgery as determined by the study radiation oncologist
All patients must have evidence of small cell lung cancer in their tissue sample, either from the primary tumor or from a metastatic site show original
Patients are required to sign an agreement indicating that they are aware of the investigational nature of this study in accordance with the policies of the hospital. show original
Patients should have normal coagulation (international normalized ratio [INR] < 1.3) and be able to withhold anticoagulation/antiplatelet medications a minimum of 24 hours prior to radiosurgery treatment (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery treatment has concluded
Patient's primary language is English
Patients who have Eastern Cooperative Oncology Group (ECOG) scores of 3 or less are eligible for this study. show original
A patient may be enrolled in the study if they have 5 or less brain metastases that are visible on a contrast-enhanced brain MRI scan obtained within the past 6 weeks show original
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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 36 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 36 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 36 months.
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 Radiosurgery will improve 1 primary outcome and 13 secondary outcomes in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Time from SRS till SCLC-related death or last follow-up, assessed up to 36 months.

Small cell lung cancer (SCLC)-specific survival
TIME FROM SRS TILL SCLC-RELATED DEATH OR LAST FOLLOW-UP, ASSESSED UP TO 36 MONTHS
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
TIME FROM SRS TILL SCLC-RELATED DEATH OR LAST FOLLOW-UP, ASSESSED UP TO 36 MONTHS
Time to neurocognitive decline
TIME FROM DATE OF SRS TILL THE COGNITIVE DECLINE, ASSESSED UP TO 36 MONTHS
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
TIME FROM DATE OF SRS TILL THE COGNITIVE DECLINE, ASSESSED UP TO 36 MONTHS
Time duration from SRS to whole brain radiation therapy (WBRT)
TIME FROM SRS TO THE START OF WBRT TREATMENT, ASSESSED UP TO 36 MONTHS
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
TIME FROM SRS TO THE START OF WBRT TREATMENT, ASSESSED UP TO 36 MONTHS
Overall survival
TIME FROM SRS UNTIL DEATH OR LAST FOLLOW-UP, ASSESSED UP TO 36 MONTHS
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
TIME FROM SRS UNTIL DEATH OR LAST FOLLOW-UP, ASSESSED UP TO 36 MONTHS
Change in neurocognitive score
BASELINE, UP TO 36 MONTHS
Will summarize and illustrate the change from baseline in neurocognitive score. Will also model the cognitive data with mixed effects regression including baseline neurocognitive scores, time, and number of lesions, extra-cranial disease, and a patient specific random effect.
BASELINE, UP TO 36 MONTHS
Rate of intracranial toxicity of SRS in the setting of prior WBRT
UP TO 36 MONTHS
Will be summarized according to intensity and treatment relationship, and categorized by System Organ Class.
UP TO 36 MONTHS
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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 causes small cell lung carcinoma?

Multiple epidemiologic, genetic, and environmental risk factors combine to influence SCLC, with little evidence to suggest one dominant risk factor. Thus, there is little evidence that smoking plays a significant role in SCLC tumorigenesis.

Anonymous Patient Answer

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

The [age of] people diagnosed with SCLC has increased since 1970 with age specific ranges at 5.2-60 years, and a median age of 51 years. A trend to increase in incidence between 1940 and 1975 is seen at 5.2-60 years with the greatest rise in incidence of 15.8% and age 50-59 years with a decrease of 1.02%.

Anonymous Patient Answer

What are the signs of small cell lung carcinoma?

Patients with small cell lung carcinoma may experience sudden onset of weakness in both arms and legs or chest pain that is relieved by breathing slowly or taking deep breaths. Dyspnoea is the most common presenting symptom. Radiographic abnormalities, including lymphedema, mediastinal lymphadenopathy and chest pain, are useful to diagnose SCLC, especially when they occur together.

Anonymous Patient Answer

How many people get small cell lung carcinoma a year in the United States?

Based on existing data, it is estimated that about 7,100 new cases, or 0.25 cases per 100,000 people per year, develop SCLC in the United States.

Anonymous Patient Answer

What are common treatments for small cell lung carcinoma?

The mainstay of the treatment of metastatic disease consists of chemotherapy, including platinum-based regimens and non-taxane chemotherapy. As with the local disease, surgery is sometimes used to improve symptoms, to provide palliative care, and to try to eradicate the disease in the patient's heart and/or bone marrow. Radiation therapy for bone metastases may provide a good initial improvement in pain and the ability to continue ambulatory function. As of 2018, no systematic treatment has been demonstrated to improve survival of patients with SCLCs. Further treatment of SCLCs will depend on the patient's response to treatment and the extent of disease. All patients with SCLCs require careful follow-up to monitor if relapse occurs.

Anonymous Patient Answer

Can small cell lung carcinoma be cured?

SCLC is generally not cured and the prognosis is poor, with patients experiencing a median survival of 8–10 months. There may be potential benefits of anti-angiogenic and anti-inflammatory therapies to improve patients' survival, but their role needs to be thoroughly tested in appropriately powered studies.

Anonymous Patient Answer

What is small cell lung carcinoma?

The five-year survival rate of SCLLC was 17%. In comparison, survival rates for SCLC for most years were over 10%. This difference is likely attributable to differences in histology and TNM staging. Early detection of SCLLC with PSA screening or CT or MRI are important for early and accurate diagnosis; early diagnosis and treatment are critical for the long-term health of SCLLC patients.

Anonymous Patient Answer

Does stereotactic radiosurgery improve quality of life for those with small cell lung carcinoma?

Significant reduction in health-related QoL was seen 1 yr postSRS. More than a third of patients reported a dramatic improvement in their QoL. PostSRS patient education and counseling should include discussion of QoL benefit.

Anonymous Patient Answer

What is the survival rate for small cell lung carcinoma?

SCLC has a strong correlation with environmental factors. In most cases it is not associated with smoking or a history of tobacco use. There is no evidence of a difference in survival rate between men and women. More than half of the patients die of SCLC before the age of 70 years. Ten-year overall and disease-specific survival are 20% and 6%, respectively. Patients with stage III or poorer stage IV disease have a worse outcome.

Anonymous Patient Answer

Who should consider clinical trials for small cell lung carcinoma?

The potential benefits of clinical trials for patients with small cell carcinoma is uncertain because of significant heterogeneity between trials and the paucity of published data for the effect of specific therapies. A comprehensive assessment of the potential benefits and risks of the therapies in addition to a comprehensive risk-benefit analysis is needed in the decision-making process.

Anonymous Patient Answer

Has stereotactic radiosurgery proven to be more effective than a placebo?

Single-fraction SRS with a treatment plan employing single-fraction SRS with a 2.0-Gy isopentic dose to the gross tumor volume (GTV) has been shown, when given concurrently with and after conventional 3D-CRT, to be more effective than a placebo in the treatment of metastasized and recurrent GBM, as well as in the palliative treatment of relapsed/refractory low-grade gliomas. SRS has been demonstrated to be effective both in treating tumors located in multiple brain areas (multifocal lesions) and for the treatment of tumors located in multiple areas of the brain-spinal junction (multifocal lesions).

Anonymous Patient Answer

What are the chances of developing small cell lung carcinoma?

Those with history of asbestos exposure or smoking tobacco for more than 20 years had a 20-fold increased risk of developing SCLC. A risk of developing SCLC was increased with advancing age. Among patients aged 65 years and older, there was no indication of increased risk of SCLC. The risk of developing SCLC seemed to be increased, particularly in men who reported smoking cigarettes.

Anonymous Patient Answer
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