Stereotactic Body Radiation Therapy for Un-biopsied Early- Stage Non Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Registration Number
- NCT02950337
- Lead Sponsor
- Loyola University
- Brief Summary
Lung cancer is the leading cause of cancer death in both men and women in the United States. In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and bronchus, resulting in 159,260 deaths. Per the current National Comprehensive Cancer Network (NCCN) guidelines, the standard of care for early-stage non-small cell lung cancer (NSCLC) is lobectomy with lymph node dissection. Historically, medically inoperable early-stage NSCLC patients have been offered definitive external beam radiotherapy (EBRT) as primary management but, overall, studies have consistently shown poor patient outcomes. Stereotactic body radiation therapy (SBRT) is a technique which delivers very high doses of radiation per fraction over one to five fractions to precisely defined volumes with steep dose gradients. SBRT is commonly utilized for the treatment of biopsy-proven early stage NSCLC in the medically inoperable patient.
- Detailed Description
This purpose of this study is to learn about the good and bad effects of treating early stage lung cancer without having a biopsy of the tumor. Participants in this research will receive a type of radiation treatment called Stereotactic Body Radiation Therapy (SBRT). This type of radiation is targeted directly at the tumor so that damage to surrounding normal tissue can be avoided. SBRT is often used in treating patients with biopsy proven early stage lung cancer who cannot have surgery for medical reasons. In this study, SBRT is considered experimental because the tumor has not been biopsied. SBRT for early-stage NSCLC has consistently proven to provide excellent local control and improved overall survival in the medically inoperable patient. The constancy of this finding over a variety of dose schedules confirms the robustness of SBRT. This study will utilize 54 Gy in 3 fractions delivered twice weekly for peripheral lesions. In order to respect the increased risk of adverse events our dose for centrally located lesions will be reduced to 50 Gy in 5 fractions delivered twice weekly and for chest wall or rib adjacent lesions will be 60 Gy in 5 fractions. These doses are consistent with Radiation Therapy Oncology Group (RTOG) 0236 for peripheral lesions and RTOG 0813 for central lesions and are both ≥100 Gy Biological Effective Dose (BED) as previously discussed . The investigators of this study routinely prescribe 60 Gy in 5 fractions for rib adjacent lesions.
The primary objective is to assess acute and chronic toxicities associated with SBRT of unbiopsied early-stage NSCLC.
Secondary objectives include:
To evaluate the disease specific outcomes of local control, lobar failure-free survival, regional/nodal failure-free survival, distant metastasis-free survival, disease-free survival, cause-specific survival, and overall survival associated with SBRT of unbiopsied early-stage NSCLC patients.
To evaluate Pulmonary Function Test (PFT) changes over time following SBRT of unbiopsied early-stage NSCLC patients.
To evaluate the patient's overall quality of life before and after treatment with SBRT of unbiopsied early-stage NSCLC patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 41
Not provided
-
• Prior history of lung cancer.
- Prior local therapy (surgery or radiotherapy) for the current, clinically-diagnosed NSCLC.
- Patients receiving any other investigational agents.
- Patients with a known history of malignancy with a disease-free interval <3 years prior to enrollment or a history of brain metastases
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that could limit compliance with study requirements.
- Patients who are currently pregnant or nursing due to the potential for congenital abnormalities and potential harm to nursing infants.
- Patients enrolled on a competing investigational study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Toxicity Evaluation 104 weeks Radiation related acute and chronic pulmonary grade 3-5 toxicity as defined by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 Toxicity evaluations will be done at weekly on treatment visits and at follow up visits for up to 104 weeks.
- Secondary Outcome Measures
Name Time Method Disease Specific Outcomes 104 weeks Patients will be classified at week 104 as having (1) disappearance of the treated lesion (i.e., complete response), (2) at least 30% decrease in the diameter of the treated lesion (i.e., partial response), (3) at least 20% increase in the diameter of the treated lesion (i.e., progressive disease), or (4) Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (i.e., stable disease). Disease outcomes will be assessed during follow up exams up to 104 weeks.
Trial Locations
- Locations (2)
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Edward Hines Jr, VA Hospital
🇺🇸Hines, Illinois, United States