Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Procedure: conventional surgery Radiation: stereotactic body radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Primary tumor control at 2 years [ Time Frame: From start of treatment to 2 years. ] [ Designated as safety issue: No ]
- Rate of treatment-related grade 3 or 4 toxicity [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
- Other grade 3-5 adverse events [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
- Primary tumor failure, marginal failure, regional failure, metastatic dissemination, disease-free survival, and overall survival at 2 years [ Time Frame: From start of treatment to 2 years. ] [ Designated as safety issue: No ]
- Level of comorbidity burden on morbidity and efficacy [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: No ]
- Prediction of primary tumor control at 2 years and treatment-related adverse events ≥ grade 2 [ Time Frame: From start of treatment to 2 years. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SBRT 20 Gy/fraction for 3 fractions
Stereotactic Body Radiation Therapy (SBRT)20 Gy per fraction for 3 fractions over 1.5 - 2 weeks for a total of 60 Gy
|
Procedure: conventional surgery Radiation: stereotactic body radiation therapy |
Detailed Description:
OBJECTIVES:
Primary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer.
Secondary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity.
- Estimate the disease-free survival and the overall survival rate at 2 years.
- Observe patterns of failure in the first 2 years.
- Assess the level of comorbidity burden on morbidity and efficacy.
- Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities
OUTLINE: This is a multicenter study.
Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with disease progression undergo surgical resection as salvage local therapy.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years and then annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Large cell neuroendocrine tumor
- 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 primary tumor, regional nodes, metastasis (TNM) staging:
- T1, N0, M0
- T2 (≤ 5 cm), N0, M0
- 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
- 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:
- Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon)
- Baseline forced expiratory volume (FEV)_1 > 35% predicted
- Postoperative predicted FEV_1 > 30% predicted
- Diffusion capacity > 35% predicted
- No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) > 50 mm Hg) at baseline
- No severe pulmonary hypertension
- No severe cerebral, cardiac, or peripheral vascular disease
- 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
- 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/mm³
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- 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:
- Dose-painting delivery techniques, including intensity-modulated radiotherapy allowed
No prior radiotherapy for lung cancer
- 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, non-approved systemic therapy, and surgery), except at disease progression
Contacts and Locations| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Alta Bates Summit Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| Mercy Cancer Center at Mercy San Juan Medical Center | |
| Carmichael, California, United States, 95608 | |
| Marin Cancer Institute at Marin General Hospital | |
| Greenbrae, California, United States, 94904 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Indiana | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Lacks Cancer Center at Saint Mary's Health Care | |
| Grand Rapids, Michigan, United States, 49503 | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-9446 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Texas | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| INOVA Alexandria Hospital | |
| Alexandria, Virginia, United States, 22304 | |
| United States, Washington | |
| St. Joseph Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Robert D. Timmerman, MD | Simmons Cancer Center |
| Study Chair: | Elizabeth M. Gore, MD | Medical College of Wisconsin |
| Study Chair: | Harvey I. Pass, MD | New York University School of Medicine |
| Study Chair: | Martin J. Edelman, MD | University of Maryland Greenebaum Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00551369 History of Changes |
| Other Study ID Numbers: | CDR0000571744, RTOG-0618 |
| Study First Received: | October 30, 2007 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Radiation Therapy Oncology Group:
|
stage I non-small cell lung cancer stage II non-small cell lung cancer adenocarcinoma of the lung |
large cell lung cancer squamous cell lung cancer adenosquamous cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013