ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Cancer

This study is currently recruiting participants.
Verified by Accuray Incorporated, March 2008

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   

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, 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


Accuray Website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Accuray Incorporated ( Omar Dawood, MD, MPH )
Study ID Numbers:   ACCL001.0
First Received:   March 20, 2008
Last Updated:   March 20, 2008
ClinicalTrials.gov Identifier:   NCT00643318
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
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers