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

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ClinicalTrials.gov Identifier: NCT00551369
Recruitment Status : Completed
First Posted : October 31, 2007
Results First Posted : October 27, 2016
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

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 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 or disease Intervention/treatment Phase
Lung Cancer Radiation: SBRT Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : December 2007
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SBRT
Stereotactic body radiation therapy (SBRT)
Radiation: SBRT
SBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
Other Names:
  • Stereotactic body radiation therapy
  • Stereotactic ablative radiotherapy
  • SABR




Primary Outcome Measures :
  1. Primary Tumor Control at 2 Years [ Time Frame: From start of treatment to 2 years. ]
    Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.


Secondary Outcome Measures :
  1. Rate of Treatment-related Grade 3 or 4 Toxicity [ Time Frame: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis. ]
    The development of any treatment-related toxicity from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy

  2. Other Grade 3-5 Adverse Events [ Time Frame: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis. ]
    The development of any treatment-related toxicity not from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy

  3. Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years [ Time Frame: From start of treatment to 2 years. ]
    PTF: the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure) within the first two years after start of SBRT. RF: the development of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum within the first two years after start of SBRT. MD: the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer within the first two years after start of SBRT. DFS: the state of being alive without development of progressive disease, with failure considered the earliest development of either progression or death. OS: the state of being alive, with failure is considered death due to any cause.

  4. Level of Comorbidity Burden on Morbidity and Efficacy [ Time Frame: From start of treatment to end of follow-up. ]
  5. Assessment of Predictive Value of Blood Markers for Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2 [ Time Frame: From start of treatment to 2 years. ]
    Assess 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 adverse events. Unfortunately, there were not enough specimens submitted to perform this analysis. The specimens that were collected remain in the NRG Oncology Biobank and are available to be combined with other specimens from other studies for an appropriately powered project.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  • 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

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): NCT00551369


Locations
Show Show 19 study locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
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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 NYU Langone Health
Study Chair: Martin J. Edelman, MD University of Maryland Greenebaum Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00551369    
Other Study ID Numbers: RTOG-0618
CDR0000571744
First Posted: October 31, 2007    Key Record Dates
Results First Posted: October 27, 2016
Last Update Posted: April 30, 2019
Last Verified: March 2019
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:
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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