CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer

Status unconfirmed · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.

Key facts

Study ID

NCT00643318

Run by

Accuray Incorporated

People needed

40

Starts

2006-04-01

Expected to finish

2021-12-01

Last updated by the study team

2021-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be over the age of 18 years
• Pulmonary nodule with maximum diameter ≤ 5 cm
• Histological confirmation of primary NSCLC
• 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)
• ECOG/Zubrod status of 0, 1 or 2
• 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.
• 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:
• FEV1 < 50% or predicted postoperative FEV1 < 40%
• DLCO < 50% or predicted postoperative DLCO < 40%
• Exercise induced maximal exercise oxygen consumption M VO2 < 15 mL/kg/min
• 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:
• Age > 75
• Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg)
• Oxygen requirement (using the Medicare criteria for home oxygen requirements [i.e., room air oxygen saturation of 88% or less])
• Resting or exercise arterial pO2 ≤ 55 mm Hg OR SpO2 ≤ 88%.
• pCO2 > 45 mm Hg

You may not qualify if…

• Excluding the primary cancer targeted for this treatment, the patient has a prior history of cancer (within the last 5 years) or concurrent cancer other than basal cell or squamous skin cancer.
• 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.
• The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch.
• The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past.
• The patient has completed chemotherapy within less than 30 days of treatment.
• 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.
• Pancoast tumors would be excluded.
• Current distant metastatic disease (M1) (preferably biopsy proven).
• The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment.
• The patient is pregnant or a female who is nursing an infant.
• The patient is planning on undergoing systemic therapy within 2 weeks after the last fraction of radiation
• The patient has an active systemic or pulmonary infection.

Where it is running

• 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

Full record on ClinicalTrials.gov

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