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

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Radiation: CyberKnife Stereotactic Radiosurgery
Phase II

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Efficacy Study
Official Title: A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Accuray Incorporated:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 156
Study Start Date: April 2006
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643318

Contacts
Contact: Joanne N Davis, PhD 248-719-2998 jdavis@accuray.com
Contact: Omar Dawood, MD, MPH 408-789-4457 odawood@accuray.com

Locations
United States, Arizona
St Joseph's Hospital/Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States
Contact: Theresa Thomas         theresa@azoncology.com    
United States, California
Stanford University Recruiting
Palo Alto, California, United States
Contact: Lisa Zhou, PhD         yaya@stanford.edu    
Principal Investigator: Richard Whyte, MD            
Principal Investigator: William Loo, MD            
Regional Community Hospital Active, not recruiting
Fresno, California, United States
United States, District of Columbia
Georgetown University Active, not recruiting
Washington DC, District of Columbia, United States
United States, Illinois
Northwest Community Hospital Recruiting
Arlington Heights, Illinois, United States
Contact: Josie Smudde         jsmudde@nch.org    
Principal Investigator: Stephen Nigh, MD            
United States, Indiana
St. Catherine's Hospital Recruiting
Munster, Indiana, United States, 46321
Contact: Mindy Mendoza         mmendoza@comhs.org    
Principal Investigator: David Bryant, MD            
United States, Oklahoma
St. Anthony's Hospital Recruiting
Oklahoma City, Oklahoma, United States
Contact: Vikki Harriott         vikki@swrads.org    
Principal Investigator: Clinton Medbery, MD            
United States, Pennsylvania
James Luketich, MD Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Julie Ward, RN            
Sponsors and Collaborators
Accuray Incorporated
Investigators
Study Chair: James Luketich, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Accuray Incorporated ( Omar Dawood, MD, MPH )
Study ID Numbers: ACCL001.0
Study First Received: March 20, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00643318     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Accuray Incorporated:
lung cancer
lung tumor
non-small cell lung cancer
NSCLC
CyberKnife
radiosurgery
lung surgery

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009