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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

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Procedure: computed tomography Radiation: fludeoxyglucose F 18 Radiation: hypofractionated radiation therapy Radiation: stereotactic radiosurgery Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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
Official Title: Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
Actual Study Start Date : January 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

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: 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

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: 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

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 (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

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: 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

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: 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

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



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852644


Locations
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
United States Department of Defense
Investigators
Principal Investigator: Minh Tam Truong, MD Boston Medical Center

Responsible Party: Minh Tam Truong, Chair and Associate Professor, Radiation Oncology, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00852644     History of Changes
Other Study ID Numbers: H-26701
CDR0000635119 ( Other Grant/Funding Number: Department of Defense )
First Posted: February 27, 2009    Key Record Dates
Results First Posted: January 9, 2018
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action