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Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer, Metastasis From Other Cancers

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Trial Information

Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers

SBRT is an adaptation of the principles and experience gained from stereotactic brain RT.
SBRT was developed in the early 90s at the Karolinska Institute in Stockholm, Sweden, and is
used as an accepted alternative of treatment for patients with early stage lung cancer in
many centers in Japan and a number of centers in Germany,USA and elsewhere. It is also now
being used for patients who have lung metastases and extra-thoracic disease (primary or
metastatic). Many reports indicate excellent local control (80-90% or higher) and minimal
toxicity in well selected patients treated with thoracic SBRT.

SBRT has traditionally had the following features:

1. High doses of radiation, usually in a few large fractions (it is "hypofractionated"
compared with standard radiotherapy schedules)

2. Multiple radiation beams coming from different directions in the same plane
('co-planar' beams) as well as from different directions and different planes relative
to the patient's body ('non-coplanar' beams)

3. Stereotactic beam placement, in that it is guided by a set of coordinates These
coordinates are defined in relationship to the precise location of the tumor,
determined from medical imaging (e.g. CT, MRI), rather than to a set of external marks
(tattoos) or anatomical landmarks (such as bony structures)

Inclusion Criteria:

- Histological confirmation of malignancy, unless the risks of biopsy are unacceptable
and the lesion has grown on serial CT scan and/or is PET positive.

- Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT
Brain/Bone Scan) identifying them as:

- patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2 (≤ 5cm), N0, M0; or
T3(≤ 5cm), N0, M0 chest wall primary tumors only)

- patients with a non-lung primary that is controlled and which has metastasized to the
lungs alone, in whom potentially curative surgery would otherwise be an option (e.g.
colorectal, breast, sarcoma…etc)

- the subset of patients with limited (low) volume metastatic NSCLC or other primary
site tumors whom it is felt may derive benefit from highdose SBRT treatment to the
primary or metastatic lung tumor. And in whom other sites of metastatic disease are
being treated with the desire to achieve long term control. Lesions must meet size
criteria in

- Patients who have potentially resectable disease should be considered medically
inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery
is not considered the preferred management option

- Early stage lung cancer: ≤3 parenchymal lung lesions, Metastatic disease to lungs: ≤5
parenchymal lung lesions

- Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes
that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological
evidence of lymph node spread)

- In patients with early stage primary NSCLC and a co-existing malignancy, the
co-existing malignancy must have an expected prognosis better than primary lung

- Adequate lung function to tolerate the planned stereotactic radiation

- Previous conventional RT to mediastinum/lung allowed as long as SBRT is not expected
to have a high probability of impairing lung function

- Must be ≥ 18 years of age

- Zubrod performance status must be between 0 and 3

- Women of child bearing potential and male participants must use an effective
contraceptive method

- Willing and able to give informed consent

Exclusion Criteria:

- Patients with active systemic, pulmonary or pericardial infection

- No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy),
apart from hormone therapy, is allowed

- History of active auto-immune diseases, including systemic lupus erythematous,
rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma

- Potential candidate for concurrent chemo-radiation therapy

- Patient enrollment on other studies may be permissible. This will depend on patient
and study characteristics.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine local control in patients treated with SBRT.

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

John Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Ethics Review Committee

Study ID:

UHN REB 05-0951-C



Start Date:

March 2006

Completion Date:

March 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Metastasis From Other Cancers
  • Non-small Cell Lung Cancer
  • Stereotactic radiation for Lung Cancer
  • Cone beam CT for Lung Cancer
  • PET/CT for Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis