Lung Cancer Clinical Trial
Official title:
A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment
for non-small cell lung cancer. Internal radiation uses radioactive material placed directly
into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to
send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet
known whether stereotactic body radiation therapy is more effective than surgery with or
without internal radiation therapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well surgery with or without
internal radiation therapy works compared with stereotactic body radiation therapy in
treating patients with high-risk stage IA or stage IB non-small cell lung cancer.
Status | Terminated |
Enrollment | 13 |
Est. completion date | |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Lung nodule suspicious for non-small cell lung cancer (NSCLC) - Biopsy confirmation is strongly recommended but not required; if biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on two or more of the following criteria: - Positive smoking history - Absence of benign calcifications within suspicious nodule - Activity on PET greater than normal tissue - Evidence of growth compared to previous imaging - Presence of spiculation - Tumor = 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration - All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration, CT-guided, or video-assisted thoracoscopic or open lymph node biopsy - Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection - Tumor located peripherally within the lung, defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions - Patients with non-peripheral (central) tumors are NOT eligible - No evidence of distant metastases PATIENT CHARACTERISTICS: - ECOG performance status (PS) 0, 1, or 2 - Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below: - Major criteria - FEV1 = 50% predicted - DLCO = 50% predicted - Minor criteria - Age = 75 years - FEV1 51-60% predicted - DLCO 51-60% predicted - Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization - Poor left ventricular function (defined as an ejection fraction of 40% or less) - Resting or exercise arterial pO2 = 55 mm Hg or SpO2 = 88% - pCO2 > 45 mm Hg - Modified Medical Research Council (MMRC) Dyspnea Scale = 3 - Not pregnant or nursing - Negative urine or serum pregnancy test - Fertile patients must use effective contraception - No prior invasive malignancy, unless disease-free for = 3 years prior to registration (except non-melanoma skin cancer, in-situ cancers). PRIOR CONCURRENT THERAPY: - No prior intra-thoracic radiotherapy - Prior radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted - Prior chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permitted |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | London Regional Cancer Program at London Health Sciences Centre | London | Ontario |
Canada | Hopital Notre-Dame du CHUM | Montreal | Quebec |
Canada | Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland |
United States | Emory Crawford Long Hospital | Atlanta | Georgia |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | St. Agnes Hospital Cancer Center | Baltimore | Maryland |
United States | UAB Comprehensive Cancer Center | Birmingham | Alabama |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Tufts Medical Center Cancer Center | Boston | Massachusetts |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Baylor University Medical Center - Dallas | Dallas | Texas |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | Providence Regional Cancer Partnership | Everett | Washington |
United States | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida |
United States | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin |
United States | St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York | New York |
United States | Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | M.D. Anderson Cancer Center at Orlando | Orlando | Florida |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Mayo Clinic Hospital | Phoeniz | Arizona |
United States | Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon |
United States | Valley Hospital - Ridgewood | Ridgewood | New Jersey |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | Stanford Cancer Center | Stanford | California |
United States | Stony Brook University Cancer Center | Stony Brook | New York |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
United States | York Cancer Center at Apple Hill Medical Center | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States, Canada,
Fernando HC, Timmerman R. American College of Surgeons Oncology Group Z4099/Radiation Therapy Oncology Group 1021: a randomized study of sublobar resection compared with stereotactic body radiotherapy for high-risk stage I non-small cell lung cancer. J Th — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5-year OS rate | Up to 5 years post-randomization | No | |
Secondary | Loco-regional recurrence-free survival | Up to 5 years post-randomization | No | |
Secondary | Adverse event profiles at 1, 3, 6, and 12 months post-therapy | Up to 12 months post-therapy | Yes | |
Secondary | Disease-free survival | Up to 5 years post-randomization | No | |
Secondary | Pulmonary function test values | Up to 12 months post-therapy | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|