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Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC

Phase 2
18 Years
90 Years
Open (Enrolling)
Non-Small-Cell Lung Carcinoma, Liver Cancer, Adrenal Cancer

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Trial Information

Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC

Inclusion Criteria:


- Patients with AJCC sixth edition metastatic non-small cell lung carcinoma

- Pathologic diagnosis of stage 4 non-small cell lung cancer prior to enrollment.

- Patients must have response or stable disease by RECIST criteria after 4 cycles of
first-line chemotherapy

- Maximum of number of lesions per patient will be 5 total. .

- Patients with solitary brain metastases previously treated with surgery or
stereotactic radiosurgery (+/- WBRT) and currently controlled at the time of study
enrollment are also eligible. Patients with history of brain metastases must have an
MRI showing no active brain metastases within 80 days of study enrollment. Patients
with a history of brain metastases may have up to 5 extracranial sites of disease
except for those with an untreated primary tumor where section will also

- Patients with newly diagnosed stage IV NSCLC with an untreated primary must no more
than 3 active extracranial metastatic lesions other than the primary site and
regional lymph nodes.

- Age ≥ 18 years old

- Performance Status 0-2 (ECOG)

- A signed study specific consent form is required.

Lung (only applies to patients with active lung lesions)

- Patients cannot have more than 3 lung lesions

- Local failure after surgical resection will be consider a metastatic lesion for
purposes of protocol inclusion.

- All lung lesions must be visible on CT imaging

- Cumulative diameter of lung lesions must be <7cm

- Patients may have active mediastinal disease in a single mediastinal nodal station if
he/she has not received prior mediastinal RT

- Must meet criteria regarding status of primary tumor site described in section 3.1.9.

- Must be able to anticipate achieving SBRT dosimetry guidelines

- Must have adequate lung function defined within 90 days of enrollment as: (1) Forced
Expiratory Volume in 1 second (FEV1) >30% of predicted or >800 Ml, (2) diffusing
capacity of the lung for carbon monoxide (DLCO) >30 % predicted and (3) no evidence
of actively worsening respiratory status

Liver (only applies to patients with active liver lesions

- Patients cannot have more than 3 liver lesions

- All active liver lesions must be discrete on CT or MRI imaging

- Combined diameter of all liver lesions must be <6cm

- Must be able to anticipate achieving SBRT plan per dosimetry guidelines for the

- Liver function tests (AST, ALT, total bilirubin) should be within ≤ 3 times the upper
limit of normal (ULN)

- Serum Albumin must be >2.5g/dL

- Patients cannot have active ascites.

Adrenal Gland

- Unilateral adrenal disease

- Must be able to anticipate achieving the SBRT plan per dosimetry guidelines.

Bone Lesions

- Treatment of any bone lesion is permissible if it is anticipated that the dosimetry
guidelines can be met.

Spine and Paraspinal lesions

- Patients cannot have more than 3 vertebrae or paraspinal sites involved (each
involved vertebral body or paraspinal site is scored as 1 site of disease)

- Must be no clinical or radiographic evidence of spinal cord compression

- If spinal metastases is within previously irradiated field, there must be a 6 month
interval between prior radiation course and study enrollment

- Prior spinal cord maximum dose at level of vertebral disease must be ≤50Gy

Exclusion Criteria:

- Primary tumor progression on first-line chemotherapy

- Patients with complete response to first-line chemotherapy with no measurable target
for SBRT

- >5 metastatic lesions or >3 metastatic lesions in patients with an untreated primary
site are ineligible (ipsilateral hilar and mediastinal lymph nodes are considered
part of an untreated primary site and are not counted as metastatic lesions)

- Solitary brain metastases and an untreated node positive primary tumor, without other
extracranial metastases amenable to SBRT are ineligible

- Retreatment of previously irradiated tumor will be excluded per above.

- Mediastinal lymph nodes involving multiple mediastinal nodal stations or N3 disease
are ineligible.

- Pleural effusion known to be malignant or visible of chest xray.

- Untreated brain metastases

- Bilateral adrenal metastases

- Metastases in other sites not considered amenable to SBRT

- Patients with liver metastases cannot have received prior upper abdominal radiation

- Prior radiation to spine (most commonly in treatment of primary lung cancer), cannot
have received >50Gy to the spinal cord at the level of current vertebral metastases

- Clinical or radiographic evidence of spinal cord compression are ineligible

- Patients with serious, uncontrolled, concurrent infection(s).

- Weight loss (>10% of body weight) in the prior 3 months.

- Pregnant or lactating women

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

Measured by imaging every 3 months

Outcome Time Frame:

Estimated time of 1 to 3 years

Safety Issue:


Principal Investigator

James Urbanic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University


United States: Institutional Review Board

Study ID:

CCCWFU 62110



Start Date:

August 2010

Completion Date:

August 2014

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Liver Cancer
  • Adrenal Cancer
  • lung cancer
  • metastatic
  • SBRT
  • Stereotactic body radiation therapy
  • liver
  • spine
  • adrenal
  • bone cancer
  • Spinal Column
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Liver Neoplasms
  • Lung Neoplasms
  • Adrenal Gland Neoplasms



Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Coastal Carolina Radiation Oncology Wilmington, North Carolina  28401