CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer
NCT ID: NCT00643318
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2006-04-30
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer
NCT00840749
Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer
NCT00238602
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
NCT00002624
Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer
NCT02250378
Transthoracic vs Transbronchial Ablation for Lung Cancer
NCT06503744
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CyberKnife Stereotactic Radiosurgery
CyberKnife Stereotactic Radiosurgery
Central tumors defined as \< 2 cm from carina and \< 2 cm from right and left mainstem bronchus and/or \< 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy)
Peripheral tumors are defined as being \> 2 cms from the carina and \> 2 cms from the right and left mainstem bronchus and/or \> 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CyberKnife Stereotactic Radiosurgery
Central tumors defined as \< 2 cm from carina and \< 2 cm from right and left mainstem bronchus and/or \< 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy)
Peripheral tumors are defined as being \> 2 cms from the carina and \> 2 cms from the right and left mainstem bronchus and/or \> 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Pulmonary nodule with maximum diameter ≤ 5 cm
3. Histological confirmation of primary NSCLC
4. The following stage of NSCLC patients are eligible:
* Stage I: T1 N0 M0 or T2 N0 M0 (Tumor size ≤ 5 cm)
* Stage II: T3 N0 M0 (Chest wall invasion only, Tumor size ≤ 5 cm)
5. ECOG/Zubrod status of 0, 1 or 2
6. Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine that the patient is not a surgical candidate.
7. In order to be considered medically inoperable, the patient must meet at least one major criteria or a minimum of 2 minor criteria as described below:
MAJOR CRITERIA:
1. FEV1 \< 50% or predicted postoperative FEV1 \< 40%
2. DLCO \< 50% or predicted postoperative DLCO \< 40%
3. Exercise induced maximal exercise oxygen consumption M VO2 \< 15 mL/kg/min
4. High-risk cardiac disease: Any one of the following:
* Poor left ventricular function (defined as an ejection fraction of \<=20%)
* Unstable coronary syndromes (unstable angina or severe angina Canadian class III or IV).
* Severe valvular disease (critical valvular stenosis),
* Recent myocardial infarction (\< 1 month),
* Significant arrhythmia defined by one of the following: High-grade AV block, Symptomatic ventricular arrhythmias in the presence of underlying heart disease, Supraventricular arrhythmias with uncontrolled ventricular rate
MINOR CRITERIA:
1. Age \> 75
2. Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg)
3. Oxygen requirement (using the Medicare criteria for home oxygen requirements \[i.e., room air oxygen saturation of 88% or less\])
4. Resting or exercise arterial pO2 ≤ 55 mm Hg OR SpO2 ≤ 88%.
5. pCO2 \> 45 mm Hg
6. Congestive heart failure (any three of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales, or congestion)
7. Moderately depressed left ventricular function (defined as an ejection fraction of 21-40% or less)
8. Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease
9. Diabetes Mellitus with severe organ damage such as ESRD, Blindness, Vascular disease.
10. Severe end organ damage from other causes resulting in ESRD, cirrhosis of the liver or vascular disease
11. FEV1 51%-60% or predicted postoperative FEV1 41-50%
12. DLCO 51-60% or predicted postoperative DLCO 41-50%
13. Modified Medical Research Council Dyspnea Scale ≥ grade 3
8. Females of child-bearing age must be using a reliable form of birth control.
9. The patient must have a PET-CT scan within 8 weeks of registration.
10. The patient must provide a signed and dated written informed consent PRIOR to registration and prior to undergoing any study-related procedures.
11. The patient must provide written authorization to allow the use and disclosure of their protected health information.
Exclusion Criteria
2. Visible endobronchial lesion seen in the trachea, carina, major bronchus, lobar or segmental bronchus on bronchoscopy or microscopic disease detected in the trachea, carina, major bronchus, lobar or segmental bronchus.
3. The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch.
4. The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past.
5. The patient has completed chemotherapy within less than 30 days of treatment.
6. T2: Tumor size \> 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and ≤ 5 cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described criteria would be excluded.
7. Pancoast tumors would be excluded.
8. Current distant metastatic disease (M1) (preferably biopsy proven).
9. The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment.
10. The patient is pregnant or a female who is nursing an infant.
11. The patient is planning on undergoing systemic therapy within 2 weeks after the last fraction of radiation
12. The patient has an active systemic or pulmonary infection.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pittsburgh
OTHER
Accuray Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Luketich, MD
Role: STUDY_CHAIR
University of Pittsburgh Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Joseph's Hospital/Barrow Neurological Institute
Phoenix, Arizona, United States
Community Regional Medical Center
Fresno, California, United States
Stanford University
Palo Alto, California, United States
Penrose Cancer Center
Colorado Springs, Colorado, United States
Denver CyberKnife
Lone Tree, Colorado, United States
North Florida Radiation Oncology
Gainesville, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Advocate Christ Med Center
Oak Lawn, Illinois, United States
Parkview Cancer Center
Fort Wayne, Indiana, United States
St. Catherine's Hospital
Munster, Indiana, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
St. Louis University Hospital
St Louis, Missouri, United States
St. Mary's Regional Medical Center
Reno, Nevada, United States
St. Anthony's Hospital
Oklahoma City, Oklahoma, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Baylor Research Institute
Dallas, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Multicare Health System
Tacoma, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Ruikang Hospital
Nanning, Guangxi, China
Tianjin Medical University Cancer Institution and Hospital
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Accuray Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACCL001.0
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.