CLINICAL TRIAL

Radiation Therapy for Carcinoma, Small Cell

Metastatic
Recruiting · 18+ · All Sexes · Atlanta, GA

This study is evaluating whether radiation therapy may help treat small cell lung cancer.

See full description

About the trial for Carcinoma, Small Cell

Eligible Conditions
Carcinoma, Small Cell · Small Cell Lung Carcinoma · Extensive Stage Small Cell Lung Carcinoma

Treatment Groups

This trial involves 2 different treatments. Radiation Therapy 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 & 3 and have had some early promising results.

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

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080

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:
CT chest, abdomen and pelvis or whole body PET/CT scan any time after the fourth cycle of chemotherapy and prior to registration
Absolute neutrophil count (ANC) >= 1,000/cells/mm^3 (within 14 days prior to registration)
Pathologically proven diagnosis of extensive stage small cell lung cancer
Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission tomography [PET]/computed tomography [CT] scan, diagnostic CT scan, magnetic resonance imaging [MRI] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide/platinum or 6 weeks from completion of prophylactic cranial irradiation (PCI)
At the time of enrollment, patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
History/physical examination within 14 days prior to registration;
MRI brain with contrast or CT brain with contrast
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
Platelets >= 75,000 cells/mm^3 (within 14 days prior to registration)
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 6 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 6 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 6 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 Radiation Therapy will improve 2 primary outcomes, 6 secondary outcomes, and 1 other outcome in patients with Carcinoma, Small Cell. Measurement will happen over the course of From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years.

Progression-free survival (PFS) (Phase II)
FROM RANDOMIZATION TO ANY DOCUMENTED PROGRESSION OR DEATH DUE TO ANY CAUSE, WHICHEVER OCCURS FIRST, ASSESSED UP TO 6 YEARS
Will compare the distributions of PFS between treatment arms using a one-sided stratified log-rank test in all randomized eligible patients. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Results from an unstratified analysis will also be provided.
FROM RANDOMIZATION TO ANY DOCUMENTED PROGRESSION OR DEATH DUE TO ANY CAUSE, WHICHEVER OCCURS FIRST, ASSESSED UP TO 6 YEARS
Overall survival (OS) (Phase III)
FROM RANDOMIZATION TO THE DATE OF DEATH DUE TO ANY CAUSE, ASSESSED UP TO 6 YEARS
Will compare arm I to arm 2 based on OS using a stratified log-rank test. Hazard ratios will be estimated using a stratified Cox regression model. Event rates over time will be estimated within each treatment group using the Kaplan-Meier method.
FROM RANDOMIZATION TO THE DATE OF DEATH DUE TO ANY CAUSE, ASSESSED UP TO 6 YEARS
Tumor burden
UP TO 6 YEARS
Tumor burden determined by central radiographic assessment, using both tumor number and tumor volume will be associated with PFS and OS benefit. The PFS and OS will be similarly summarized and compared between experimental and control in the following subgroups: 1) high or low tumor burden, using >= 4, 5, or 6 metastases as a cutoff; 2) high or low tumor burden, using the median of centrally reviewed radiographic tumor volume as a cutoff.
UP TO 6 YEARS
PFS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease
UP TO 6 YEARS
UP TO 6 YEARS
OS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors
UP TO 6 YEARS
Will be similarly summarized and compared between experimental and control. The interaction between the treatment groups and tumor number groups will also be explored in Cox regression model.
UP TO 6 YEARS
PFS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors
UP TO 6 YEARS
Will be similarly summarized and compared between experimental and control. The interaction between the treatment groups and tumor number groups will also be explored in Cox regression model.
UP TO 6 YEARS
See More

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 is carcinoma, small cell?

Contrary to common belief, in most cases SCLC originates in the lung, specifically the main lobe. SCLC can also originate other organs in the thorax and abdomen but are uncommon. Most people with SCLC have an underlying COPD diagnosis. SLEs in SCLC differ from those found in other cancers with an increased incidence of metastatic disease and a shorter time between the diagnosis of SLE and the concurrent diagnosis of SCLC (2.6 months versus 1 year, respectively).

Anonymous Patient Answer

What are common treatments for carcinoma, small cell?

Treatment of Small-cell carcinoma is focused on the main organs affected by metastasis, as well as the primary site of the cancer. A combination of surgery, chemotherapy (CT), and radiotherapy (RT) may be used. RT may be given to the primary cancer site. Survival rates are dependent on the extent of disease, tumour and patient demographics, as well as the type and amount of chemotherapy or RT. Survival rates in SCLC are around 10% as of 2005.\n

Anonymous Patient Answer

What causes carcinoma, small cell?

The cause of carcinoma, small cell, is not understood. Genetic and environmental factors are likely to work within the same pathway, which could explain several key features that occur in those patients with carcinoma, small cell. These include the tendency of this cancer to form at younger ages, to affect women more than men, and to spread as far as the lungs, brain, and bone.

Anonymous Patient Answer

What are the signs of carcinoma, small cell?

Carcinomas, small cell may present with painless nodules on routine exams. Invasive carcinoma, small cell, is often associated with significant weight loss, night sweats, pain or stiffness with deep palpitation, chest or back pain, and/or decreased quality of life.

Anonymous Patient Answer

Can carcinoma, small cell be cured?

There is no convincing evidence of cure for carcinoma, small cell with or without adenocarcinoma. Further clinical trials are desirable to determine the role of chemotherapy in this disease.

Anonymous Patient Answer

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

Carcinoma, small-cell, makes up about 2 percent of all U.S. deaths in 2018. Around 19,000 people per year will be diagnosed with carcinoma, small-cell a year in the United States.

Anonymous Patient Answer

What is the survival rate for carcinoma, small cell?

Patients who present with SCC should not be denied the opportunity to receive treatment, but, the clinical results for this disease are generally poor. In specific cases, such as in younger patients with an early and localized disease, patients should be offered aggressive treatment including the options of chemotherapy or surgery followed by radiotherapy. Also, patients who present with advanced disease and are not eligible for radiation therapy should be offered multimodality therapy consisting of surgery, chemotherapy, and radiotherapy.

Anonymous Patient Answer

What is radiation therapy?

In addition to having a significant decrease in tumor size, CRT (Conventionally radiation therapy) also has an improvement in cosmetic quality of life for patients with head and neck malignancies. In addition to the improvement of cosmetic quality of life, CRT also results in a decreased number of treatment cycles, fewer treatment delays, less discomfort associated with treatment, and an overall improvement in quality of life for patients with head and neck malignancies.

Anonymous Patient Answer

How serious can carcinoma, small cell be?

Carcinoma, small cell is [typically] not a very aggressive carcinoma, only appearing in patients who have a very good prognosis. So, it will not be possible to predict from its size or other features whether it will be aggressive or not. For this reason, a combination of parameters like lymph node count and tumor stage is usually more informative than a single predictive parameter like stage.

Anonymous Patient Answer

What is the primary cause of carcinoma, small cell?

The majority of carcinoma of small cell origin is [unexplained or intrinsic to the tumor or its microenvironment] and [of unknown etiology] with intrinsic small cell cancer being caused by a combination of [epigenetic mutation in the tumor cells, a post-transcriptional defect, or a combination of both abnormalities] according to the WHO classification of carcinoma.

Anonymous Patient Answer

What are the common side effects of radiation therapy?

Although the majority of side effects (83%) obtained in the study are relatively common, most were transient and manageable. Radiation therapy with modern machines is safe. Side effects and toxicity can be reduced when radiation is carefully applied and tailored to the clinical situation.

Anonymous Patient Answer

What are the chances of developing carcinoma, small cell?

1/3 of cases of carcinoma develop simultaneously in the lung and thyroid. 1/3 of small cell carcinoma cases have a paraneoplastic syndrome. Carcinoma and SCLC often occur in tandem, one following another. If 1 patient in a thousand in your cohort has lung carcinoma, have an aggressive investigation to find the underlying paraneoplastic syndrome and use [Power] to look for lung carcinoma clinical trials.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Small Cell by sharing your contact details with the study coordinator.