Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00551369
First received: October 30, 2007
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor.

PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.


Condition Intervention Phase
Lung Cancer
Procedure: conventional surgery
Radiation: stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Primary tumor control at 2 years [ Time Frame: From start of treatment to 2 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of treatment-related grade 3 or 4 toxicity [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
  • Other grade 3-5 adverse events [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
  • Primary tumor failure, marginal failure, regional failure, metastatic dissemination, disease-free survival, and overall survival at 2 years [ Time Frame: From start of treatment to 2 years. ] [ Designated as safety issue: No ]
  • Level of comorbidity burden on morbidity and efficacy [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: No ]
  • Prediction of primary tumor control at 2 years and treatment-related adverse events ≥ grade 2 [ Time Frame: From start of treatment to 2 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: December 2007
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT 20 Gy/fraction for 3 fractions
Stereotactic Body Radiation Therapy (SBRT)20 Gy per fraction for 3 fractions over 1.5 - 2 weeks for a total of 60 Gy
Procedure: conventional surgery Radiation: stereotactic body radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer.

Secondary

  • Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity.
  • Estimate the disease-free survival and the overall survival rate at 2 years.
  • Observe patterns of failure in the first 2 years.
  • Assess the level of comorbidity burden on morbidity and efficacy.
  • Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with disease progression undergo surgical resection as salvage local therapy.

After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years and then annually thereafter.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Large cell carcinoma
    • Large cell neuroendocrine tumor
    • Non-small cell carcinoma not otherwise specified
  • No pure type bronchoalveolar cell carcinoma
  • Stage I or II disease based on 1 of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging:

    • T1, N0, M0
    • T2 (≤ 5 cm), N0, M0
    • T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
  • No T2 or T3 primary tumors > 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum
  • No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi)
  • Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0

    • Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer
  • No direct evidence of regional or distant metastases after appropriate staging studies
  • Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria:

    • Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon)
    • Baseline forced expiratory volume (FEV)_1 > 35% predicted
    • Postoperative predicted FEV_1 > 30% predicted
    • Diffusion capacity > 35% predicted
    • No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) > 50 mm Hg) at baseline
    • No severe pulmonary hypertension
    • No severe cerebral, cardiac, or peripheral vascular disease
    • No severe chronic heart disease
  • Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray

    • Pleural effusion that appears on chest x-ray will be allowed only after thoracotomy or other invasive procedure

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count ≥ 1,800/mm³
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer
  • No active systemic, pulmonary, or pericardial infection
  • No weight loss > 5% for any reason within the past 3 months

PRIOR CONCURRENT THERAPY:

  • Dose-painting delivery techniques, including intensity-modulated radiotherapy allowed
  • No prior radiotherapy for lung cancer

    • Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields
  • No prior chemotherapy or surgical resection for this lung cancer
  • No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, non-approved systemic therapy, and surgery), except at disease progression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551369

Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States, 94904
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Indiana
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9446
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Virginia
INOVA Alexandria Hospital
Alexandria, Virginia, United States, 22304
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Robert D. Timmerman, MD Simmons Cancer Center
Study Chair: Elizabeth M. Gore, MD Medical College of Wisconsin
Study Chair: Harvey I. Pass, MD New York University School of Medicine
Study Chair: Martin J. Edelman, MD University of Maryland Greenebaum Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00551369     History of Changes
Other Study ID Numbers: CDR0000571744, RTOG-0618
Study First Received: October 30, 2007
Last Updated: May 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
adenocarcinoma of the lung
large cell lung cancer
squamous cell lung cancer
adenosquamous 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 18, 2013