Back to resultsSurgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
surgery
brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria: PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION) Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC) Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement) Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2 Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below: Major criteria Forced expiratory volume in 1 second (FEV1) =< 50% predicted Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted Minor criteria Age >= 75 FEV1 51-60% predicted DLCO 51-60% predicted Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization Poor left ventricular function (defined as an ejection fraction of 40% or less) Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88% Partial pressure of carbon dioxide (pCO2) > 45 mm Hg Modified Medical Research Council (MMRC) Dyspnea Scale >= 3 Patient must not have had previous intra-thoracic radiation therapy Women of child-bearing potential must have negative serum or urine pregnancy test No prior invasive malignancy, unless disease-free for >= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers) PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION) Patient must have biopsy-proven NSCLC Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on positron emission tomography [PET] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)
Sites / Locations
- Mayo Clinic Scottsdale
- University of California Davis Cancer Center
- Mayo Clinic - Jacksonville
- Winship Cancer Institute of Emory University
- Evanston Hospital
- Cancer Institute at St. John's Hospital
- Regional Cancer Center at Memorial Medical Center
- Simmons Cooper Cancer Institute
- Cancer Institute at St. Joseph Medical Center
- Boston University Cancer Research Center
- University of Michigan Comprehensive Cancer Center
- Mayo Clinic Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Valley Hospital - Ridgewood
- South Nassau Communities Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- SUNY Upstate Medical University Hospital
- Presbyterian Cancer Center at Presbyterian Hospital
- Charles M. Barrett Cancer Center at University Hospital
- Knight Cancer Institute at Oregon Health and Science University
- Jameson Memorial Hospital - North Campus
- Abramson Cancer Center of the University of Pennsylvania
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- Allegheny Cancer Center at Allegheny General Hospital
- UPMC Cancer Centers
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Rhode Island Hospital Comprehensive Cancer Center
- Miriam Hospital
- U.T. Medical Center Cancer Institute
- Methodist Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- University of Virginia Cancer Center
- Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- London Regional Cancer Program at London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I
Arm II
Arm Description
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Outcomes
Primary Outcome Measures
Time to Local Recurrence
Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
Secondary Outcome Measures
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Number of Participants Reported Local Recurrence at 3 Years
Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.
Number of Participants Reported Regional Recurrence at 3 Years
Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.
Number of Participants Reported Distant Recurrence at 3 Years
Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant> metastatic disease (other organs).
Mortality Rates at 30- and 90-day After Sublobar Resection
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection
The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..
FEV1% Measured at Baseline and Month 3
Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms
DLCO% Measured at Baseline and Month 3
Pulmonary function tests included percentage predicted carbon
> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.
Full Information
NCT ID
NCT00107172
First Posted
April 5, 2005
Last Updated
October 4, 2019
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00107172
Brief Title
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Official Title
A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2005 (Actual)
Primary Completion Date
April 18, 2013 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery 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. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum [N1 nodes], or progression at the staple line after treatment effects such as scarring have subsided).
SECONDARY OBJECTIVES:
I. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence.
V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin.
After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Primary Outcome Measure Information:
Title
Time to Local Recurrence
Description
Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death due to any cause.
Time Frame
Up to 5 years
Title
Number of Participants Reported Local Recurrence at 3 Years
Description
Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.
Time Frame
3 years
Title
Number of Participants Reported Regional Recurrence at 3 Years
Description
Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.
Time Frame
3 years
Title
Number of Participants Reported Distant Recurrence at 3 Years
Description
Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant> metastatic disease (other organs).
Time Frame
3 years
Title
Mortality Rates at 30- and 90-day After Sublobar Resection
Time Frame
90 days
Title
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Description
Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Time Frame
90 days
Title
Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection
Description
The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.
Time Frame
90 days
Title
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Description
Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.
Time Frame
24 months
Title
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Description
Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..
Time Frame
24 months
Title
FEV1% Measured at Baseline and Month 3
Description
Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms
Time Frame
3 months
Title
DLCO% Measured at Baseline and Month 3
Description
Pulmonary function tests included percentage predicted carbon
> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)
Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC)
Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration
Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2
Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:
Major criteria
Forced expiratory volume in 1 second (FEV1) =< 50% predicted
Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted
Minor criteria
Age >= 75
FEV1 51-60% predicted
DLCO 51-60% predicted
Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
Poor left ventricular function (defined as an ejection fraction of 40% or less)
Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%
Partial pressure of carbon dioxide (pCO2) > 45 mm Hg
Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
Patient must not have had previous intra-thoracic radiation therapy
Women of child-bearing potential must have negative serum or urine pregnancy test
No prior invasive malignancy, unless disease-free for >= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)
PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)
Patient must have biopsy-proven NSCLC
Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on positron emission tomography [PET] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiran C. Fernando, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Cancer Institute at St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Simmons Cooper Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9677
Country
United States
Facility Name
Cancer Institute at St. Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Valley Hospital - Ridgewood
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
South Nassau Communities Hospital
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Jameson Memorial Hospital - North Campus
City
New Castle
State/Province
Pennsylvania
ZIP/Postal Code
16105
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Allegheny Cancer Center at Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
U.T. Medical Center Cancer Institute
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920-6999
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17909906
Citation
Smith RP, Schuchert M, Komanduri K, Burton S, Heron DE, Luketich JD, d'Amato T, Landreneau R. Dosimetric evaluation of radiation exposure during I-125 vicryl mesh implants: implications for ACOSOG z4032. Ann Surg Oncol. 2007 Dec;14(12):3610-3. doi: 10.1245/s10434-007-9624-0. Epub 2007 Oct 2.
Results Reference
background
PubMed Identifier
21872277
Citation
Fernando HC, Landreneau RJ, Mandrekar SJ, Hillman SL, Nichols FC, Meyers B, DiPetrillo TA, Heron DE, Jones DR, Daly BD, Starnes SL, Tan A, Putnam JB. Thirty- and ninety-day outcomes after sublobar resection with and without brachytherapy for non-small cell lung cancer: results from a multicenter phase III study. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1143-51. doi: 10.1016/j.jtcvs.2011.07.051. Epub 2011 Aug 26.
Results Reference
result
PubMed Identifier
21724195
Citation
Fernando HC, Landreneau RJ, Mandrekar SJ, Hillman SL, Nichols FC, Meyers B, DiPetrillo TA, Heron D, Jones DR, Daly BD, Starnes SL, Hatter JE, Putnam JB. The impact of adjuvant brachytherapy with sublobar resection on pulmonary function and dyspnea in high-risk patients with operable disease: preliminary results from the American College of Surgeons Oncology Group Z4032 trial. J Thorac Cardiovasc Surg. 2011 Sep;142(3):554-62. doi: 10.1016/j.jtcvs.2010.10.061. Epub 2011 Jul 2.
Results Reference
result
PubMed Identifier
24982457
Citation
Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, Hillman SL, Heron DE, Meyers BF, DiPetrillo TA, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB Jr. Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer. J Clin Oncol. 2014 Aug 10;32(23):2456-62. doi: 10.1200/JCO.2013.53.4115. Epub 2014 Jun 30.
Results Reference
result
PubMed Identifier
25500100
Citation
Fernando HC, Landreneau RJ, Mandrekar SJ, Nichols FC, DiPetrillo TA, Meyers BF, Heron DE, Hillman SL, Jones DR, Starnes SL, Tan AD, Daly BD, Putnam JB; Alliance for Clinical Trials in Oncology. Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: results from the ACOSOG Z4032 (Alliance) multicenter randomized trial. J Thorac Cardiovasc Surg. 2015 Mar;149(3):718-25; discussion 725-6. doi: 10.1016/j.jtcvs.2014.11.003. Epub 2014 Nov 13.
Results Reference
result
Learn more about this trial
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
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