Stereotactic Body Radiotherapy for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
2
Safety
Philadelphia CyberKnife, Philadelphia, PA
+3 More
Stereotactic Body Radiotherapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a combination of radiation and immunotherapy may be effective for individuals with lung cancer.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Metastatic Non-Small Cell Lung Cancer
  • Lung Neoplasms
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Stereotactic Body Radiotherapy will improve 2 primary outcomes and 4 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 0-15 weeks.

0-15 weeks
Acute Toxicity: Radiation pnuemonitis measured using NCI CTCAE version 4.0
0-24 Months
Local Control
24 Months
Impact of Tumor Burden
24 months
Overall Survival
3-24 Months
Progression Free Survival
6-24 Months
Late Toxicity: Pulmonary, Bone or Visceral organ toxicity evaluated 6 months from completion of treatment using NCI CTCAE version 4.

Trial Safety

Side Effects for

SBRT With Gem
ulcer
15%
vomiting
10%
pain
5%
Perforation
5%
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00350142) in the SBRT With Gem ARM group. Side effects include: ulcer with 15%, vomiting with 10%, pain with 5%, Perforation with 5%.

Trial Design

2 Treatment Groups

Control
Treatment Arm

This trial requires 3 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stereotactic Body Radiotherapy 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.

Treatment Arm
Radiation
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy
2008
Completed Phase 2
~220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6-24 months for reporting.

Who is running the study

Principal Investigator
R. L. M.
Rachelle Lanciano M.D., Principal Investigator
Crozer-Keystone Health System

Closest Location

Philadelphia CyberKnife - Philadelphia, PA

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Histologically or cytologically confirmed Stage IV NSCLC according to the 7th AJCC staging manual.
Eligible for an immunotherapy agent. Patients who progress after drug therapy (3 months) for ALK, EGFR or ROS mutation positive lung cancer are eligible.
At least 2 lesions that are safely amenable to SBRT. ECOG <=2.
At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment or at least 1 lesion with FDG avidity and CT correlate that can be monitored for PET-CT response by SUV Max increase or decrease.
Normal Hepatic and renal function.
ANC ≥ 1.5 x 109/L
Hemoglobin ≥9.0 g/dL
Platelet count ≥75 x 109/L
Ability to comply with follow-up visits and evaluations, treatment planning and studies and other study related procedures and visits.
Ability to sign informed consent.

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 signs of carcinoma, non-small-cell lung?

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Carcinomas are typically identified from symptoms and medical history. The physical exam is often negative in an early stage. Symptoms generally improve as the cancer progresses and may mimic symptoms of COPD, chronic bronchitis, emphysema or acute respiratory distress syndrome.

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Can carcinoma, non-small-cell lung be cured?

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In contrast to what was previously reported in cases of small-cell lung cancer, in NSCLC and probably in other malignant neoplasms, there are no data confirming the efficacy of chemotherapy and/or radiation therapy in inducing local or systemic remission of carcinoma, non-small-cell lung.

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What causes carcinoma, non-small-cell lung?

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As a group, carcinoma, non-small-cell lung cases are not associated with genetic risk factors, environmental factors, or exposure to drugs, carcinogens, or radiation. The pathogenesis of lung cancer is related to the occurrence of cigarette carcinoma, and the mechanisms are not fully known. However, lung carcinoma is associated with chronic, often sublethal, cigarette smoking.

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What is carcinoma, non-small-cell lung?

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Cancer, non-small-cell lung, a neoplasm is classified as a form of malignancy which is generally thought to be the result of uncontrolled cell growth. In the case of carcinoma non-small-cell lung, it is a particular type of malignancy that is a type of cancer. The pathogenesis of lung carcinoma, non-small-cell lung, has not been well understood although it is believed to arise from the transformation of a small percentage of the lung tumors cells. The disease is highly correlated to viral infection and smoking.

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What are common treatments for carcinoma, non-small-cell lung?

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Tobacco smoking, radiation and chemotherapy are the most important treatments in NSCLC. Other treatments such as gene therapy"

"Flux (mutation)\n\nThe term "flux" has become used in the mutation genetics field by analogy to the English verb "flux" - "to flow, rush, run", used in the expression "the flux of the modern world" as well as in the names "Fluxator", "Flicker", and "Fluxator Fluxator".

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

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Around 1,300 to 1,900 new cases of lung cancer are diagnosed in the US each year. About 400 deaths are due to lung cancer each year.

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Who should consider clinical trials for carcinoma, non-small-cell lung?

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These data suggest that smokers should be considered for clinical trials for NSCLC, but patients having a history of lung cancer, diabetes, or chronic obstructive pulmonary disease (COPD) should be approached with caution.

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What are the common side effects of stereotactic body radiotherapy?

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These side effects can be controlled and prevented by proper patient selection, and regular medical examinations and follow-ups. When a lesion is found in the patient, it is usually not possible to treat the complete tumor; so after the treatment, the lesion returns, and some part of its volume remains.

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Is stereotactic body radiotherapy safe for people?

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Findings from a recent study of this study are encouraging and demonstrate the safe use of shortcourse SBRT for the treatment of locally advanced NSCLC.

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How quickly does carcinoma, non-small-cell lung spread?

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Results from a recent clinical trial showed that the time of diagnosis was significantly shorter in the patients with non-local disease. Although the survival rate of the patients with non-local disease was significantly longer, the survival time of the patients with non-recurrent disease was the shortest among the three groups. Therefore, early diagnosis and early treatment should be aimed at the patients with non-local disease.

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What are the chances of developing carcinoma, non-small-cell lung?

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(3) The average time between the initial presentation of pulmonary malignancy and lung metastasis in patients with lung and non-small-cell-lung cancer was 15.6 years. (4) The incidence of lung metastasis and death in patients with lung and non-small-cell-lung cancer, in particular, in patients with advanced disease, was high.

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

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The mean age of non-small-cell lung carcinoma detection is higher than the mean age of colon carcinoma diagnosis (59.9 years vs 50.4 years). The peak age is also higher for non-small-cell lung carcinoma (62.0 yr vs 52.3 yr). Non-small-cell lung carcinoma is more common among female patients, compared with male patients (4:1).

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