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CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Cancer
This study is currently recruiting participants.
Study NCT00643318   Information provided by Accuray Incorporated
First Received: March 20, 2008   Last Updated: January 8, 2009   History of Changes

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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
Contact: Joanne N Davis, PhD 248-719-2998 jdavis@accuray.com
Contact: Omar Dawood, MD, MPH 408-789-4457 odawood@accuray.com
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP