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Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

Contact Information

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Julian Hong
(650) 736-0798
julianhong@stanford.edu

Recruiting Status: Recruiting

Stanford Recruiting Status: Recruiting

Investigator(s):

Description:

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor. PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.

Conditions Studied:

Lead Sponsor: RTOG

Collaborator(s):

Intervention(s):

Phase: Phase 2


Eligibility

Key Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types:
o Squamous cell carcinoma
o Adenocarcinoma
o Large cell carcinoma
o Large cell neuroendocrine tumor
o Non-small cell carcinoma not otherwise specified

- No pure type bronchoalveolar cell carcinoma

- Stage I or II disease based on 1 of the following combinations of TNM staging:
o T1, N0, M0
o T2 (<= 5 cm), N0, M0
o T3 (<= 5 cm), N0, M0 (chest wall primary tumors only)

- No T2 or T3 primary tumors > 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum

- No primary tumor of any T-stage 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 (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi)

- Patients with hilar or mediastinal lymph nodes <= 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0
o Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer

- No direct evidence of regional or distant metastases after appropriate staging studies

- Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria:
o Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon)
o Baseline FEV_1 > 40% predicted
o Postoperative predicted FEV_1 > 30% predicted
o Diffusion capacity > 40% predicted
o No hypoxemia and/or hypercapnia at baseline
o Exercise oxygen consumption > 50% predicted
o No severe pulmonary hypertension
o No severe cerebral, cardiac, or peripheral vascular disease
o No severe chronic heart disease

- Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray
o Pleural effusion that appears on chest x-ray will be allowed only after thoracotomy or other invasive procedure

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1
- Absolute neutrophil count >= 1,800/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 8.0 g/dL (transfusion allowed)
- FEV_1 >= 1.5 L/sec (best value obtained pre- or post-bronchodilator)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer
- No active systemic, pulmonary, or pericardial infection
- No weight loss > 5% for any reason within the past 3 months

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy for lung cancer
o Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields
- No prior chemotherapy or surgical resection for this lung cancer

- No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, nonapproved systemic therapy, and surgery), except at disease progression

- No concurrent intensity-modulated radiotherapy

Key Exclusion Criteria:

Ages Eligible for Study: 18 years to Any Age

Genders Eligible for Study: Male and Female

Healthy Volunteers?: People with the conditions listed in this trial can not participate as controls.

Additional Study Details

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

Anticipated start date: 6/9/2008

Study Type: Interventional

Purpose: Treatment

Allocation: Non-randomized

Masking: Open

Control: none

Assignment: Single Group

Endpoints: Efficacy

Primary Outcomes:

Secondary Outcomes:

Total Number to be Enrolled: 33

Total Number to be Enrolled at Stanford: 10


More Information

Trial Unique Id: SU-07242008-1267

Secondary ID(s)


Locations & Contacts
Stanford Locations & Contacts

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Julian Hong
(650) 736-0798
julianhong@stanford.edu

Non-Stanford Locations

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated: 9/2/2009

PLEASE NOTE: Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or email referral@medcenter.stanford.edu .

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