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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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
 Procedure: computed tomography
Radiation: fludeoxyglucose F 18
Radiation: hypofractionated radiation therapy
Radiation: stereotactic radiosurgery
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: January 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852644

Locations
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen     617-638-8265        
Sponsors and Collaborators
Boston Medical Center
Department of Defense
Investigators
Principal Investigator: Lisa A. Kachnic, MD Boston Medical Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00852644     History of Changes
Other Study ID Numbers: CDR0000635119, BUMC-H-26701
Study First Received: February 26, 2009
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013