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

Not Recruiting

Trial ID: NCT00643318


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.

Official Title

A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non-Small Cell Lung Cancer (NSCLC)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Professor of Medicine (Oncology)

Quynh-Thu Le, MD
Quynh-Thu Le, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

Joseph Shrager
Joseph Shrager

Professor of Cardiothoracic Surgery

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)

Kathleen Horst, MD
Kathleen Horst, MD

Professor of Radiation Oncology (Radiation Therapy)

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD

Professor of Radiology (Interventional Radiology)


Professor of Radiation Oncology (Radiation Therapy)

Nishita Kothary, MD
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)


Inclusion Criteria:

   1. Patient must be over the age of 18 years

   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:


      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


      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

      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

   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:

   1. 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.

   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.


radiation: CyberKnife Stereotactic Radiosurgery

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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