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Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Phase 1/Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients



- To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT)
in medically inoperable patients with centrally located stage I non-small cell lung
cancer. (Phase I)

- To determine the efficacy of SBRT when administered at the MTD in these patients.
(Phase I)

- To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)


- To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade
3 that is possibly, probably, or definitely related to treatment and that occurs within
1 year after the start of SBRT in these patients.

- To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of
SBRT) in these patients.

- To estimate the local control and progression-free and overall survival rates in
patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5
fractions) in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


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

- Stage T1-2, N0, M0 disease

- Tumor size ≤ 5 cm

- Tumor must be 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 (i.e., 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) OR immediately adjacent to the
mediastinal or pericardial pleura (PTV touching the pleura)

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

- Mediastinal lymph node sampling by any technique is allowed but not

- Patients with > 1 cm hilar or mediastinal lymph nodes 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

- Tumor deemed technically resectable, in the opinion of an experienced thoracic cancer
surgeon, with a reasonable possibility of obtaining a gross total resection with
negative margins, defined as a potentially curative resection (PCR)

- Patient deemed "medically inoperable" due to severe underlying physiological medical
problems that would prohibit a PCR, 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 as documented by CT scan or whole-body PET scan within the past 8

- Patients with lesions that cannot be visualized by CT scan are not eligible

- Pleural effusion allowed provided it is deemed too small to tap under CT guidance and
is not evident on chest x-ray

- Pleural effusion that appears on chest x-ray is allowed only after thoracotomy
or other invasive procedure


- Zubrod performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 60 days after
completion of study therapy

- No other invasive malignancy within the past 2 years except nonmelanomatous skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- Prior lung cancer allowed provided the patient has been disease-free for ≥ 2


- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiotherapy fields

- No prior chemotherapy for the study cancer

- No other concurrent local therapy (including standard-fractionated radiotherapy
and/or surgery) or systemic therapy (including standard chemotherapy or biologic
targeted agents) specifically intended as treatment for study cancer

- Local or systemic therapy at the time of disease progression allowed

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of stereotactic body radiotherapy (SBRT) as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 (Phase I)

Outcome Time Frame:

From start of SBRT until 1 year.

Safety Issue:


Principal Investigator

Andrea Bezjak, MD, MSC, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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