Lung Cancer Clinical Trial

Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.

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Full Description

OBJECTIVES:

Primary

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

Secondary

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 (FX)] in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 2 years, then annually.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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 positron emission tomography (PET) scan are considered N0

Mediastinal lymph node sampling by any technique is allowed but not required
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 weeks

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

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
Not pregnant
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 years

PRIOR CONCURRENT THERAPY:

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT00750269

Recruitment Status:

Completed

Sponsor:

Radiation Therapy Oncology Group

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There are 57 Locations for this study

See Locations Near You

Arizona Center for Cancer Care - Peoria
Peoria Arizona, 85381, United States
Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank California, 91505, United States
Radiation Oncology Centers - Cameron Park
Cameron Park California, 95682, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael California, 95608, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain Connecticut, 06050, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Baptist Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
M.D. Anderson Cancer Center at Orlando
Orlando Florida, 32806, United States
OSF St. Francis Medical Center
Peoria Illinois, 61637, United States
CCOP - Kansas City
Prairie Village Kansas, 66208, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington Kentucky, 40536, United States
Norton Suburban Hospital
Louisville Kentucky, 40207, United States
Tulane Cancer Center Office of Clinical Research
Alexandria Louisiana, 71315, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough Maine, 04074, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
McLaren Cancer Institute
Flint Michigan, 48532, United States
Butterworth Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak Michigan, 48073, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
Saint Louis University Cancer Center
Saint Louis Missouri, 63110, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cooper CyberKnife Center
Mount Laurel New Jersey, 08054, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta New Jersey, 07871, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York New York, 10025, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York New York, 10032, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Flower Hospital Cancer Center
Sylvania Ohio, 43560, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg Pennsylvania, 18301, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia Pennsylvania, 19114, United States
Albert Einstein Cancer Center
Philadelphia Pennsylvania, 19141, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee Wisconsin, 53295, United States
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT00750269

Recruitment Status:

Completed

Sponsor:


Radiation Therapy Oncology Group

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