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A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer



- To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably,
or possibly related to treatment with single fraction vs multiple fraction stereotactic
body radiotherapy in medically inoperable patients with stage I peripheral non-small
cell lung cancer.


- To estimate the 1-year primary tumor control rate in these patients.

- To estimate the 1-year overall survival and disease-free survival rate of these

- To assess FDG-PET standardized uptake value changes as a measure of treatment response
and outcomes.

- To determine pulmonary function changes by treatment arm and response.

- To determine the association between biomarkers and primary tumor control and/or ≥
grade 2 radiation pneumonitis.

OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod
performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2
treatment arms.

- Arm I (single fraction): Patients undergo one stereotactic body radiotherapy (SBRT)
treatment to the target lesion.

- Arm II (multiple fractions): Patients undergo SBRT to the target lesion once daily for
4 days.

Blood and tumor tissue samples may be collected for further analysis.

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

Inclusion Criteria


- Histologically or cytologically confirmed primary non-small cell lung cancer,
including one of the following subtypes:

- Squamous cell carcinoma

- Adenocarcinoma

- Large cell carcinoma

- Large cell neuroendocrine carcinoma

- Non-small cell carcinoma not otherwise specified

- Stage T1-2, N0, M0 disease

- Tumor size ≤ 5 cm

- Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal
uptake on PET scan are considered N0

- Patients with hilar or mediastinal lymph nodes > 1 cm on CT scan or
abnormal PET scan (including suspicious but nondiagnostic uptake) are
eligible provided directed tissue biopsies of all abnormally identified
areas are negative for cancer

- No regional or distant metastases

- Peripherally located tumor

- No primary tumor 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, right and
left lower lobe bronchi)

- No involvement of the central pleura and/or structures of the mediastinum

- Resectable disease

- Patient may have declined surgery after consulting with a thoracic surgeon

- Patient deemed "medically inoperable", in the opinion of an experienced thoracic
cancer clinician (thoracic surgeon, medical oncologist, radiation oncologist, or
pulmonologist), due to a severe underlying physiological medical problem that would
preclude surgery, including any of the following:

- Baseline forced expiratory volume at one second (FEV1) < 40% predicted

- Postoperative FEV1 < 30% predicted

- Severely reduced diffusion capacity

- Baseline hypoxemia and/or hypercapnia

- Exercise oxygen consumption < 50% predicted

- Severe pulmonary hypertension

- Diabetes mellitus with severe end-stage organ damage

- Severe cerebral, cardiac, or peripheral vascular disease

- Severe chronic heart disease

- Measurable disease


- Zubrod performance status 0-2

- Absolute neutrophil count (ANC) ≥ 1,800/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No synchronous primary malignancy or other malignancy within the past 2 years except
for any of the following:

- Invasive malignancy that was definitively treated and patient remains disease
free for > 3 years with a life expectancy of > 3 years

- Carcinoma in situ

- Early stage skin cancer that was definitively treated

- No active systemic, pulmonary, or pericardial infection


- No prior radiotherapy to the lung or mediastinum

- No prior chemotherapy for this lung or mediastinal tumor

- Prior chemotherapy for another invasive malignancy allowed provided it was
definitively treated and patient remains disease free for > 3 years

- No prior surgery for this lung or mediastinal tumor

- No other concurrent antineoplastic therapy, including standard fractionated
radiotherapy, chemotherapy, biological therapy, vaccine therapy, and/or surgery

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment

Outcome Time Frame:

From start of treatment to 1 year

Safety Issue:


Principal Investigator

Gregory Videtic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • squamous cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
CCOP - Kansas City Kansas City, Missouri  64131
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Memorial Hospital of South Bend South Bend, Indiana  46601
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
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
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Community Cancer Center Normal, Illinois  61761
OSF St. Francis Medical Center Peoria, Illinois  61637
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Great Lakes Cancer Institute at McLaren Regional Medical Center Flint, Michigan  48532
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Flower Hospital Cancer Center Sylvania, Ohio  43560
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Parkview Regional Cancer Center at Parkview Health Fort Wayne, Indiana  46805
Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg, Pennsylvania  18301
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Veterans Affairs Medical Center - Milwaukee Milwaukee, Wisconsin  53295
Auburn Radiation Oncology Auburn, California  95603
Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
Inova Alexandria Hospital Alexandria, Virginia  22304
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608