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

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ClinicalTrials.gov Identifier: NCT00852644
Recruitment Status : Terminated (poor accrual)
First Posted : February 27, 2009
Results First Posted : January 9, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Minh Tam Truong, Boston Medical Center

February 26, 2009
February 27, 2009
February 13, 2017
January 9, 2018
May 11, 2018
January 2009
June 2013   (Final data collection date for primary outcome measure)
  • Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort [ Time Frame: 6 weeks ]
    Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
  • Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort [ Time Frame: 6 weeks ]
    The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
  • Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort [ Time Frame: 6 weeks ]
    The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
  • Maximum Tolerated Dose - More Than 3 Centimeter Cohort. [ Time Frame: 6 weeks ]
    The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
  • Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
  • 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
Complete list of historical versions of study NCT00852644 on ClinicalTrials.gov Archive Site
Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival [ Time Frame: before treatment and at 1, 3, 6, and 12 months after treatment ]
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
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 positron emission tomography (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
Not Applicable
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Participants to receive Cyberknife radiation therapy in 4 doses over two weeks. Dose will be determined using a dose-escalation plan.
Masking: None (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
  • Experimental: 56 Gray (LESS than 3 centimeter cohort)

    Intervention:

    Procedure/Surgery: computed tomography Standard CT scans

    Intervention:

    Radiation: fludeoxyglucose F 18 standard doses with CT scans

    Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray

    Radiation: stereotactic radiosurgery CyberKnife radiosurgery

    Interventions:
    • Procedure: computed tomography
    • Radiation: fludeoxyglucose F 18
    • Radiation: hypofractionated radiation therapy
    • Radiation: stereotactic radiosurgery
  • Experimental: 62 Gray (LESS than 3 centimeter cohort)

    Intervention:

    Procedure/Surgery: computed tomography Standard CT scans

    Intervention:

    Radiation: fludeoxyglucose F 18 standard doses with CT scans

    Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray

    Radiation: stereotactic radiosurgery CyberKnife radiosurgery

    Interventions:
    • Procedure: computed tomography
    • Radiation: fludeoxyglucose F 18
    • Radiation: hypofractionated radiation therapy
    • Radiation: stereotactic radiosurgery
  • Experimental: 68 Gray (LESS than 3 centimeter cohort)

    Intervention:

    Procedure/Surgery: computed tomography Standard CT scans

    Intervention:

    Radiation: fludeoxyglucose F 18 standard doses with CT scans

    Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray

    Radiation: stereotactic radiosurgery CyberKnife radiosurgery

    Interventions:
    • Procedure: computed tomography
    • Radiation: fludeoxyglucose F 18
    • Radiation: hypofractionated radiation therapy
    • Radiation: stereotactic radiosurgery
  • Experimental: 56 Gray (MORE than 3 centimeter cohort)

    Intervention:

    Procedure/Surgery: computed tomography Standard CT scans

    Intervention:

    Radiation: fludeoxyglucose F 18 standard doses with CT scans

    Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray

    Radiation: stereotactic radiosurgery CyberKnife radiosurgery

    Interventions:
    • Procedure: computed tomography
    • Radiation: fludeoxyglucose F 18
    • Radiation: hypofractionated radiation therapy
    • Radiation: stereotactic radiosurgery
  • Experimental: 62 Gray (MORE than 3 centimeter cohort)

    Intervention:

    Procedure/Surgery: computed tomography Standard CT scans

    Intervention:

    Radiation: fludeoxyglucose F 18 standard doses with CT scans

    Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray

    Radiation: stereotactic radiosurgery CyberKnife radiosurgery

    Interventions:
    • Procedure: computed tomography
    • Radiation: fludeoxyglucose F 18
    • Radiation: hypofractionated radiation therapy
    • Radiation: stereotactic radiosurgery
  • Experimental: 68 Gray (MORE than 3 centimeter cohort)

    Intervention:

    Procedure/Surgery: computed tomography Standard CT scans

    Intervention:

    Radiation: fludeoxyglucose F 18 standard doses with CT scans

    Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray

    Radiation: stereotactic radiosurgery CyberKnife radiosurgery

    Interventions:
    • Procedure: computed tomography
    • Radiation: fludeoxyglucose F 18
    • Radiation: hypofractionated radiation therapy
    • Radiation: stereotactic radiosurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
36
August 2016
June 2013   (Final data collection date for primary outcome measure)

Inclusion 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)
  • Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"

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

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (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

Exclusion Criteria:

  • No history of contrast allergy
  • No psychological issues that would preclude the completion of study treatment

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or chemotherapy
  • 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)
  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00852644
H-26701
CDR0000635119 ( Other Grant/Funding Number: Department of Defense )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Plan to Share IPD: No
Minh Tam Truong, Boston Medical Center
Boston Medical Center
United States Department of Defense
Principal Investigator: Minh Tam Truong, MD Boston Medical Center
Boston Medical Center
April 2018

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