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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
OBJECTIVES:
Primary
- Compare time to local recurrence, in terms of recurrence within the same lobe or hilum
(N1 nodes) or progression at the staple line (after treatment effects [i.e., scarring]
have subsided), in high-risk patients with stage I non-small cell lung cancer treated
with sublobar resection with vs without intraoperative brachytherapy.
Secondary
- Compare procedure-specific morbidity and mortality in patients treated with these
regimens.
- Compare overall and failure-free survival of patients treated with these regimens.
- Compare freedom from regional or distant recurrence in patients treated with these
regimens.
- Determine the effect of histologically or cytologically positive resection margins on
time to local recurrence in patients treated with these regimens.
- Determine the effect of brachytherapy on quality of life of these patients.
- Determine the effect of brachytherapy on pulmonary function in these patients.
OUTLINE: This is a randomized, multicenter study. 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 an iodine I 125 implant at the resection margin.
Quality of life is assessed at baseline and then at 3, 12, and 24 months.
After completion of study treatment, patients are followed at 3 and 6 months, every 6 months
for 2.5 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this
study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Suspected or proven non-small cell lung cancer (NSCLC), meeting both of the following
criteria:
- Pre-operative criteria
- Lung nodule suspicious for clinical stage I NSCLC
- Mass ≤ 3 cm in maximum diameter by CT scan of the chest and upper
abdomen
- Clinical stage IA OR selected stage IB with visceral pleural
involvement
- Intra-operative criteria
- Histologically proven stage I NSCLC
- All suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on
CT scan OR positive on positron-emission tomography scan) must be
negative by mediastinoscopy, endoscopic ultrasound-guided needle
aspiration, or CT-guided, video-assisted thoracoscopic, or open lymph
node biopsy
- Meets ≥ 1 major OR ≥ 2 minor high-risk criteria, defined as the following:
- Major criteria
- FEV_1 ≤ 50% of predicted
- DLCO ≤ 50% of predicted
- Minor criteria
- Age 75 and over
- FEV_1 51-60% of predicted
- DLCO 51-60% of predicted
- Pulmonary hypertension, defined as pulmonary artery systolic pressure > 40
mm Hg by echocardiography or right heart catheterization
- LVEF ≤ 40%
- Resting or exercise arterial oxygen partial pressure ≤ 55 mm Hg or oxygen
saturation ≤ 88% by pulse oximetry
- Arterial carbon dioxide partial pressure > 45 mm Hg
- Modified Medical Research Council Dyspnea Scale ≥ 3
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- See Disease Characteristics
Pulmonary
- See Disease Characteristics
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 5 years since prior invasive malignancy unless non melanoma skin cancer or
in-situ cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior intrathoracic radiotherapy
Surgery
- Not specified
Other
- Concurrent enrollment on ACOSOG-Z4031 (correlative science protocol) allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time to local recurrence
Safety Issue:
No
Principal Investigator
Hiran C. Fernando, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Boston Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000422346
NCT ID:
NCT00107172
Start Date:
July 2005
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Simmons Cooper Cancer Institute | Springfield, Illinois 62794-9677 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
| Evanston Hospital | Evanston, Illinois 60201-1781 |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Methodist Hospital | Houston, Texas 77030 |
| Miriam Hospital | Providence, Rhode Island 02906 |
| Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
| Boston University Cancer Research Center | Boston, Massachusetts 02118 |
| Valley Hospital - Ridgewood | Ridgewood, New Jersey 07450 |
| South Nassau Communities Hospital | Oceanside, New York 11572 |
| U.T. Medical Center Cancer Institute | Knoxville, Tennessee 37920-6999 |
| Jameson Memorial Hospital - North Campus | New Castle, Pennsylvania 16105 |
| Cancer Institute at St. Joseph Medical Center | Towson, Maryland 21204 |
| Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center | Seattle, Washington 98111 |
