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A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer



- Determine whether treatment with stereotactic body radiotherapy results in acceptable
local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II
non-small cell lung cancer.


- Determine treatment-related toxicity in patients treated with this therapy.

- Determine disease-free survival, overall survival, and patterns of failure in patients
treated with this therapy.

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence
of disease progression or unacceptable toxicity.

Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2
years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- The following primary cancer subtypes are eligible:

- Squamous cell carcinoma

- Adenocarcinoma

- Large cell carcinoma

- Bronchoalveolar cell carcinoma

- Non-small cell carcinoma not otherwise specified

- Stage I or II disease based on 1 of the following tumor node metastasis (TNM) stage

- T1, N0, M0

- T2 (≤ 5 cm), N0, M0

- T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)

- No primary tumor of any T-stage within or touching the zone of the proximal bronchial
tree* NOTE: *Defined as a volume 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, and right and
left lower lobe bronchi)

- No primary T3 tumors involving the central chest (≤ 2 cm toward carina invasion) or
structures of the mediastinum

- Any hilar or mediastinal lymph nodes > 1 cm on CT scan OR demonstrating suspicious
uptake on positron-emission tomography scan must be biopsied and confirmed negative

- The primary tumor must be deemed technically resectable with a reasonable possibility
of obtaining a gross total resection with negative margins (defined as a potentially
curative resection (PCR))

- Deemed medically inoperable based on pulmonary function for surgical resection of
NSCLC secondary to an underlying physiological problem, including any of the
following medical conditions*:

- Baseline forced expiratory volume (FEV)_1< 40% of predicted

- Postoperative predicted FEV_1 < 30% of predicted

- Severely reduced diffusion capacity

- Baseline hypoxemia and/or hypercapnia

- Exercise oxygen consumption < 50% of predicted

- Severe pulmonary hypertension

- Diabetes mellitus with severe end organ damage

- Severe cerebral, cardiac, or peripheral vascular disease

- Severe chronic heart disease NOTE: *Patients who refuse a PCR due to preference,
ideology, emotional or psychological issues, mental illness, or inability to
give informed consent are not eligible

- No evidence of regional or distant metastases



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- See Disease Characteristics

- No active pericardial infection


- See Disease Characteristics

- No active pulmonary infection


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active systemic infection

- No other concurrent illness that would preclude study participation


Biologic therapy

- No concurrent biologic therapy

- No concurrent vaccine therapy


- No concurrent chemotherapy

Endocrine therapy

- Not specified


- No prior lung or mediastinal radiotherapy

- No concurrent standard fractionated radiotherapy

- No concurrent intensity modulated radiotherapy

- No concurrent cobalt-60 or charged particle beams (including electrons, protons, or
heavier ions)


- See Disease Characteristics

- No concurrent surgery


- No other concurrent antineoplastic therapy

Type of Study:


Study Design:

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

Outcome Measure:

Local control at 2 years

Outcome Time Frame:

From the 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:

May 2004

Completion Date:

Related Keywords:

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



M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642