Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Radiation: SBRT 42.5 GyRadiation: SBRT 40.0 GyRadiation: SBRT 50.0 GyRadiation: SBRT 45.0 GyRadiation: SBRT 55.0 GyRadiation: SBRT 60.0 GyRadiation: SBRT 47.5 GyRadiation: SBRT 52.5 GyRadiation: SBRT 57.5 Gy
- Registration Number
- NCT00750269
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Level 2: 8.5 Gy/FX SBRT 42.5 Gy SBRT 42.5 Gy Level 1: 8.0 Gy/FX SBRT 40.0 Gy SBRT 40.0 Gy Level 5: 10.0 Gy/FX SBRT 50.0 Gy SBRT 50.0 Gy Level 3: 9.0 Gy/FX SBRT 45.0 Gy SBRT 45.0 Gy Level 7: 11.0 Gy/FX SBRT 55.0 Gy SBRT 55.0 Gy Level 9: 12.0 Gy/FX SBRT 60.0 Gy SBRT 60.0 Gy Level 4: 9.5 Gy/FX SBRT 47.5 Gy SBRT 47.5 Gy Level 6: 10.5 Gy/FX SBRT 52.5 Gy SBRT 52.5 Gy Level 8: 11.5 Gy/FX SBRT 57.5 Gy SBRT 57.5 Gy
- Primary Outcome Measures
Name Time Method (Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD) From start of SBRT to 2 years. Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 From start of SBRT to 1 year Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity \<= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).
- Secondary Outcome Measures
Name Time Method Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0 From start of SBRT until 1 year. Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity.
Progression-free Survival From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
Overall Survival From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0 From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.
Nodal Progression From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Local Progression From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Distant Metastases From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Trial Locations
- Locations (58)
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Norton Suburban Hospital
🇺🇸Louisville, Kentucky, United States
Radiation Oncology Centers - Cameron Park
🇺🇸Cameron Park, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
CCOP - Kansas City
🇺🇸Prairie Village, Kansas, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Cooper CyberKnife Center
🇺🇸Mount Laurel, New Jersey, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸Orlando, Florida, United States
Arizona Center for Cancer Care - Peoria
🇺🇸Peoria, Arizona, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
🇺🇸Sparta, New Jersey, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
🇺🇸Scarborough, Maine, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
🇺🇸New York, New York, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Frankford Hospital Cancer Center - Torresdale Campus
🇺🇸Philadelphia, Pennsylvania, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Veterans Affairs Medical Center - Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
🇺🇸Burbank, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
🇺🇸Carmichael, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
McLaren Cancer Institute
🇺🇸Flint, Michigan, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
🇺🇸East Stroudsburg, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada