| March 20, 2008 |
| January 8, 2009 |
| April 2006 |
| July 2013 (final data collection date for primary outcome measure) |
| The primary objectives are to assess clinical response rate, local control, progression-free survival and overall survival, following CyberKnife stereotactic radiosurgery for patients with early stage NSCLC. [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00643318 on ClinicalTrials.gov Archive Site |
| To characterize and compare quality of life before and after stereotactic radiosurgery treatment.
To assess procedure-related outcomes after stereotactic radiosurgery of lung tumors. [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
| Same as current |
| |
| CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Cancer |
| A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non-Small Cell Lung Cancer (NSCLC) |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Efficacy Study |
| Non-Small Cell Lung Cancer |
| Radiation: CyberKnife Stereotactic Radiosurgery |
| |
| |
| |
| Recruiting |
| 156 |
| July 2013 |
| July 2013 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient must be over the age of 18 years
- Histological confirmation of primary NSCLC
- Pulmonary nodule size less than or equal to 5 cm
- The following stage of NSCLC patients are eligible:
- Stage I: T1, N0, M0 or T2, N0, M0 (Tumor size </= 5cm)
- Stage II: T3, N0, M0 (Chest wall invasion only, Tumor size </= 5cm)
- ECOG/Zubrod status of 0, 1, or 2
- In order to be considered medically inoperable, the patient must meet at least one major criteria or a minimum of 2 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/kg/min
- 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.
MINOR CRITERIA:
- Age > 80 years
- Pulmonary hypertension (defined as a pulmonary artery systolic pressure > than 40 mm Hg
- Oxygen requirement
- Congestive heart failure (any 3 of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales or congestion)
- Poor left ventricular function (defined as an ejection fraction of 40% or less)
- Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease
- Diabetes Mellitus with severe organ damage
- Females of child bearing age must be using a reliable form of birth control
- PET-CT scan completed within 6 weeks of registration
Exclusion Criteria:
- Prior history of cancer within the last 5 years or concurrent cancer other than basal cell or squamous cell carcinoma
- Weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch
- Thoracic radiation therapy in the same field as the planned treatment area
- Patient has completed chemotherapy within less than 30 days of treatment
- Stage T2 with tumor size > 5 cm; Stage T3 (except T3 by virtue of chest wall invasion only and </= 5 cm); Stage T4
- Presence of N1, N2 or N3 disease
- Pancoast tumors
- Current distant metastases (M1)
- Female with child-bearing potential who refuses to take a pregnancy test prior to treatment
- Pregnant or nursing female
- Active systemic or pulmonary infection
- Undergoing systemic therapy within 2 weeks after last fraction of radiation
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00643318 |
| Omar Dawood, MD, MPH, Accuray Incorporated |
| ACCL001.0 |
| Accuray Incorporated |
|
| Study Chair: |
James Luketich, MD |
University of Pittsburgh |
|
|
| Accuray Incorporated |
| January 2009 |