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Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
computed tomography
positron emission tomography
stereotactic body radiation therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage I non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage I or II non-small cell lung cancer meeting the following criteria:

    • No bronchoalveolar cell carcinoma
    • Maximum T2 or T3 tumor size ≤ 5 cm

      • T3 primary tumor must be limited to chest wall
    • Primary tumor of any T stage must be within or touching the zone of the trachea or proximal bronchial tree, defined as a volume of 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchi, right middle lobe bronchus, right and left lower lobe bronchi)

      • For lesions inferior to the proximal bronchial tree, the primary tumor must be within 2 cm of the esophagus
    • Patients with N1 (hilar) lymph nodes positive for malignancy based on size, fludeoxyglucose F 18 (FDG)-PET scan uptake, or biopsy are eligible if the N1 lymph nodes are located such that they are contiguously within the same stereotactic radiation treatment field as the primary tumor
    • Mediastinal lymph nodes must be ≤ 1 cm and no abnormal uptake on FDG-PET scan in those areas

      • Patients with > 1 cm lymph nodes or abnormal FDG-PET scan (including suspicious but non-diagnostic uptake) are eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer
  • No evidence of distant metastases

    • Suspected M1 disease based on pre-treatment PET imaging must be biopsied

      • If the biopsy is positive, the patient is ineligible
      • If the biopsy is negative and representative of the lesion in question, the patient is eligible
      • If the biopsy is non-diagnostic, consideration should be given to repeat biopsy

        • If the repeat biopsy remains non-diagnostic or a biopsy is not feasible, then the patient is ineligible
  • Technically resectable disease

    • Surgery refused or patient deemed medically inoperable due to co-morbid conditions

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No synchronous primary or invasive malignancy within the past 2 years other than non-melanomatous skin cancer
  • No active systemic, pulmonary, or pericardial infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chest radiotherapy (lung or mediastinum)
  • No other concurrent anticancer therapy, including other radiotherapy, radiofrequency ablation (or other antineoplastic interventional radiology techniques), chemotherapy, biological therapy, vaccine therapy, or surgery

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Maximum tolerated dose (Phase I)
    Time to progression and local control at 1 and 2 years (Phase II)

    Secondary Outcome Measures

    Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms
    Toxicity
    Patterns of failure and overall survival at 2 years
    Measurement of pre-treatment and post-treatment PET scan standardized uptake values and correlation of this data with local control at 1 and 2 years

    Full Information

    First Posted
    May 8, 2007
    Last Updated
    January 17, 2017
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00471835
    Brief Title
    Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
    Official Title
    A Phase I/II Study of Hypofractionated Stereotactic Body Radiotherapy for Stage I/II Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I or stage II non-small cell lung cancer.
    Detailed Description
    OBJECTIVES: Primary Determine the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) to the central lung region (peri-mediastinum) in patients with stage I or II non-small cell lung cancer. (Phase I) Determine local control and time to local progression in patients treated with this regimen. (Phase II) Evaluate the ability of peak standardized uptake values (SUV) for fludeoxyglucose F 18 (FDG)-PET scan, obtained shortly after SBRT (post-treatment), to predict local control and time to progression in these patients. Secondary Evaluate the ability of maximum SUV for FDG-PET scan, obtained shortly after SBRT, to predict long-term local control and time to progression in these patients. Evaluate the ability of peak SUV and max SUV for FDG-PET scan, obtained prior to SBRT, to predict local control and time to progression in these patients. Determine the utility of PET/CT scan data in guiding treatment planning. Determine if treatment with radiotherapy involving high biological doses with limited treatment volume using these SBRT techniques achieves acceptable treatment-related toxicity. OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study. Phase I: Patients undergo hypofractionated stereotactic body radiotherapy (SBRT) 3 times within a 2-week time frame. Cohorts of 3-6 patients receive escalating doses of hypofractionated SBRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II: Patients undergo hypofractionated SBRT at the MTD as in phase I. In both phases, patients undergo fludeoxyglucose F 18-PET/CT scans at baseline and at 12-16 weeks after completion of SBRT. After completion of study treatment, patients are followed periodically for 4 years. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    stage II non-small cell lung cancer, stage I non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    computed tomography
    Intervention Type
    Procedure
    Intervention Name(s)
    positron emission tomography
    Intervention Type
    Radiation
    Intervention Name(s)
    stereotactic body radiation therapy
    Primary Outcome Measure Information:
    Title
    Maximum tolerated dose (Phase I)
    Title
    Time to progression and local control at 1 and 2 years (Phase II)
    Secondary Outcome Measure Information:
    Title
    Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms
    Title
    Toxicity
    Title
    Patterns of failure and overall survival at 2 years
    Title
    Measurement of pre-treatment and post-treatment PET scan standardized uptake values and correlation of this data with local control at 1 and 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I or II non-small cell lung cancer meeting the following criteria: No bronchoalveolar cell carcinoma Maximum T2 or T3 tumor size ≤ 5 cm T3 primary tumor must be limited to chest wall Primary tumor of any T stage must be within or touching the zone of the trachea or proximal bronchial tree, defined as a volume of 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchi, right middle lobe bronchus, right and left lower lobe bronchi) For lesions inferior to the proximal bronchial tree, the primary tumor must be within 2 cm of the esophagus Patients with N1 (hilar) lymph nodes positive for malignancy based on size, fludeoxyglucose F 18 (FDG)-PET scan uptake, or biopsy are eligible if the N1 lymph nodes are located such that they are contiguously within the same stereotactic radiation treatment field as the primary tumor Mediastinal lymph nodes must be ≤ 1 cm and no abnormal uptake on FDG-PET scan in those areas Patients with > 1 cm lymph nodes or abnormal FDG-PET scan (including suspicious but non-diagnostic uptake) are eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer No evidence of distant metastases Suspected M1 disease based on pre-treatment PET imaging must be biopsied If the biopsy is positive, the patient is ineligible If the biopsy is negative and representative of the lesion in question, the patient is eligible If the biopsy is non-diagnostic, consideration should be given to repeat biopsy If the repeat biopsy remains non-diagnostic or a biopsy is not feasible, then the patient is ineligible Technically resectable disease Surgery refused or patient deemed medically inoperable due to co-morbid conditions PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No synchronous primary or invasive malignancy within the past 2 years other than non-melanomatous skin cancer No active systemic, pulmonary, or pericardial infection PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chest radiotherapy (lung or mediastinum) No other concurrent anticancer therapy, including other radiotherapy, radiofrequency ablation (or other antineoplastic interventional radiology techniques), chemotherapy, biological therapy, vaccine therapy, or surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Volker W. Stieber, MD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

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