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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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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



- 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.


- Determine whether treatment with radiotherapy involving a high biological dose with
limited treatment volume (using SBRT techniques) achieves acceptable treatment-related

- 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.

Inclusion Criteria


- 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

- No direct evidence of regional or distant metastases after appropriate staging

- 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


- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary tumor control at 2 years

Outcome Time Frame:

From start of treatment to 2 years.

Safety Issue:


Principal Investigator

Robert D. Timmerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Memorial Hospital of South Bend South Bend, Indiana  46601
University of California Davis Cancer Center Sacramento, California  95817
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Marin Cancer Institute at Marin General Hospital Greenbrae, California  94904
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
St. Joseph Cancer Center Bellingham, Washington  98225
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Inova Alexandria Hospital Alexandria, Virginia  22304
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608