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Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified November 2012 by Boston Medical Center
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00852644
First received: February 26, 2009
Last updated: November 27, 2012
Last verified: November 2012
History of Changes

February 26, 2009
November 27, 2012
January 2009
February 2013   (final data collection date for primary outcome measure)
To establish the maximally tolerated dose of CyberKnife® radiosurgery in patients with medically inoperable clinical Tl-3 N0 M0 NSCLC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery [ Designated as safety issue: Yes ]
  • Relationship between PET response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00852644 on ClinicalTrials.gov Archive Site
Relationship between PET response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging [ Time Frame: before treatment and at 1, 3, 6, and 12 months after treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.

OBJECTIVES:

  • To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
  • To establish the relationship between PET response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.

OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.

Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 4 years.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Procedure: computed tomography
    Standard CT scans
  • Radiation: fludeoxyglucose F 18
    standard doses with CT scans
  • Radiation: hypofractionated radiation therapy
    4 doses over 2 weeks
  • Radiation: stereotactic radiosurgery
    CyberKnife radiosurgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
March 2014
February 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • Stage I or II disease (T1-3, N0, M0)

      • T2 or T3 tumor ≤ 5 cm
      • No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
  • No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
  • Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"

  • No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)

    • Patients with FDG-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • No history of contrast allergy
  • No psychological issues that would preclude the completion of study treatment

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or chemotherapy
Both
18 Years and older
No
Not Provided
United States
 
NCT00852644
CDR0000635119, BUMC-H-26701
Yes
Boston Medical Center
Boston Medical Center
Department of Defense
Principal Investigator: Lisa A. Kachnic, MD Boston Medical Center
Boston Medical Center
November 2012

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