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Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC

The most common treatment for early stage lung cancers is to remove the cancer with surgery.
Patients with serious underlying health problems like emphysema, diabetes, or heart disease
who develop an early stage lung cancer may not be eligible for the standard surgical
treatment. The most common alternative to surgery is conventional radiation treatment
called fractionated radiotherapy. "Fractionated radiotherapy" means several weeks of
treatment with daily radiation sessions. While this treatment is sometimes successful at
killing the cancer, it is not as effective as surgery and may significantly damage the
surrounding lung tissue.

Newer treatments using radiotherapy have been developed and used for patients with
metastases (spreading cancer) to the lungs. Stereotactic radiotherapy uses a frame to guide
highly focused beams of radiation at the cancer while avoiding the normal surrounding
tissue. Stereotactic radiotherapy also uses a higher daily dose of radiation. The higher
daily dose may be more effective than conventional radiotherapy at killing cancer cells and
may also decrease side effects.

Inclusion Criteria:

Consistent with most therapeutic oncology trials, patients are not actively "recruited,"
but are screened by their physician for appropriate clinical trial(s) at the time of their
routine clinic visit.

All patients must be willing and capable to provide informed consent to participate in the

Eligible patients must have appropriate staging studies identifying them as AJCC stage I
(T1 or T2, N0, M0) primary lung carcinoma. The patient should not have direct evidence of
regional or distant metastases after appropriate staging studies. Histologic confirmation
will be required by either biopsy or cytology. The following primary cancer types are
eligible: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma,
bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.

The primary tumor must be deemed technically resectable by an experienced thoracic cancer
clinician, with a reasonable possibility of obtaining a gross total resection with
negative margins (defined as a potentially curative resection, PCR); however, the patient
should have underlying physiological medical problems that would prohibit a PCR due to a
low probability of tolerating general anesthesia, the operation, the post-operative
recovery period, or the removal of adjacent functioning lung. Standard "cut-off "
guidelines regarding surgical resection of NSCLC include the following: Baseline FEV1
<40%, post-operative predicted FEV1 <30%, severely reduced diffusion capacity, baseline
hypoxemia and/or hypercapnia and exercise oxygen consumption <50% predicted.

Patients who refuse a PCR due to preference, ideology, emotional or psychological issues,
mental illness, or inability to give consent for the PCR and who have no specific accepted
medical contraindications for the PCR are not eligible.

Eligible patients should not have had previous lung or mediastinal radiotherapy.

There must be no plans for the patient to receive other concomitant antineoplastic therapy
while on this protocol. Patients who have received chemotherapy within 8 weeks of the
start date of study are ineligible.

Patients must be able to fit inside the stereotactic body frame and able to undergo a CT
or MRI scan in the frame.

The patient's primary tumor must not be larger than 7.0 cm in greatest dimension.

Patients with active systemic, pulmonary, or pericardial infection are ineligible.

Pregnant or lactating women are ineligible. Women/men of reproductive potential may not
participate unless they agreed to use an effective contraceptive method such as
condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth
control pills.

Patients must be past their 18th birthday at time of registration. Karnofsky performance
status > 60.


Exclusion Criteria:

See inclusion criteria.


Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The purposes of this research study are (1) to find the highest dose of stereotactic radiotherapy that can safely be used for treatment of early stage non-small cell lung cancer.

Outcome Time Frame:

5 years from enrollment completion

Safety Issue:


Principal Investigator

Ronald McGarry, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University - Department of Radiation Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

December 1999

Completion Date:

January 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • stereotactic body radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Indiana University, Department of Radiation Oncology Indianapolis, Indiana  46202