A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer
Both
Lung Cancer
Trial Information
A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA
non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection
or segmentectomy).
Secondary
- Compare the overall survival of patients undergoing lobectomy vs sublobar resection.
- Compare the rates of loco-regional and systemic recurrence in patients undergoing
lobectomy vs sublobar resection.
- Compare the pulmonary function of these patients, as measured by expiratory flow rates
at 6 months postoperatively.
- Explore the relationship between characteristics of the primary lung cancer, as
revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and
outcomes.
- Determine the false-negative rate of preoperative PET scan for identification of
involved hilar and mediastinal lymph nodes.
- Assess the utility of annual follow-up CT scan after surgical resection in these
patients.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to tumor
size (< 1 cm vs 1-1.5 cm vs > 1.5-2.0 cm) (based on the maximum dimension determined from
the preoperative scan), histology (squamous cell carcinoma vs adenocarcinoma vs other), and
smoking status (never smoked [smoked < 100 cigarettes over lifetime] vs former smoker
[smoked > 100 cigarettes AND quit ≥ 1 year ago] vs current smoker [quit < 1 year ago or
currently smokes]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic
surgery (VATS).
- Arm II: Patients undergo a wedge resection or anatomical segmentectomy by open
thoracotomy or VATS.
After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually for 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and
intraoperative criteria:
- Preoperative criteria
- Peripheral lung nodule ≤ 2 cm by CT scan
- Center of the tumor must be located in the outer third of the lung in
either the transverse, coronal, or sagittal plan
- Tumor location must be suitable for either lobar or sublobar resection
(wedge resection or segmentectomy)
- No pure ground opacities or pathologically confirmed N1 or N2 disease
- Intraoperative criteria
- Histologically confirmed NSCLC
- Confirmation of N0 status by frozen section examination of nodal levels 4,
7, and 10 on the right side and 5, 6, 7, and 10 on the left side*
- Levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial
ultrasound (EBUS), and/or endoscopic ultrasound (EUS), or at the time
of thoracotomy or video-assisted thoracoscopic surgery (VATS)
exploration* NOTE: *Nodes previously sampled by mediastinoscopy (or
EBUS and/or EUS) either immediately before or within 6 weeks of the
definitive surgical procedure (thoracotomy or VATS) do not need to be
resampled
- No evidence of locally advanced or metastatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No other malignancy within the past 3 years except for nonmelanoma skin cancer,
superficial bladder cancer, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for this malignancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Safety Issue:
No
Principal Investigator
Nasser K. Altorki, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
Unspecified
Study ID:
CDR0000555324
NCT ID:
NCT00499330
Start Date:
June 2007
Completion Date:
Related Keywords:
- Lung Cancer
- stage IA non-small cell lung cancer
- adenocarcinoma of the lung
- squamous cell lung cancer
- large cell lung cancer
- adenosquamous cell lung cancer
- bronchoalveolar cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
| Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Veterans Affairs Medical Center - Loma Linda (Pettis) | Loma Linda, California 92357 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| St. Francis Hospital | Federal Way, Washington 98003 |
| St. Clare Hospital | Lakewood, Washington 98499-0998 |
| Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
| Good Samaritan Cancer Center | Puyallup, Washington 98371 |
| Allenmore Hospital | Tacoma, Washington 98411-0414 |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
| UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Evanston Hospital | Evanston, Illinois 60201-1781 |
| William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
| Menorah Medical Center | Overland Park, Kansas 66209 |
| Saint Luke's Hospital - South | Overland Park, Kansas 66213 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| St. Mary Mercy Hospital | Livonia, Michigan 48154 |
| St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| Heartland Hematology Oncology Associates, Incorporated | Kansas City, Missouri 64118 |
| North Kansas City Hospital | Kansas City, Missouri 64116 |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
| Research Medical Center | Kansas City, Missouri 64132 |
| Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
| Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
| Saint Joseph Oncology, Incorporated | Saint Joseph, Missouri 64507 |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
| Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
| Knox Community Hospital | Mount Vernon, Ohio 43050 |
| Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Providence Centralia Hospital | Centralia, Washington 98531-9027 |
| Columbia Basin Hematology | Kennewick, Washington 99336 |
| Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
| Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
| Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
| St. Vincent's Medical Center | Bridgeport, Connecticut 06606 |
| Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
| Duke Cancer Institute | Durham, North Carolina 27710 |
| Greenville Hospital Cancer Center | Greenville, South Carolina 29605 |
| Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
| Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
| Cancer Centers of the Carolinas - Greer Medical Oncology | Greer, South Carolina 29650 |
| Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
| Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
| Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
| Parvin Radiation Oncology | Kansas City, Missouri 64116 |
| Veterans Affairs Medical Center - Indianapolis | Indianapolis, Indiana 46202 |
| Valley Hospital - Ridgewood | Ridgewood, New Jersey 07450 |
| U.T. Medical Center Cancer Institute | Knoxville, Tennessee 37920-6999 |
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
| Cancer Centers of the Carolinas - Easley | Easley, South Carolina 29640 |
| Cancer Centers of the Carolinas - Greer Radiation Oncology | Greer, South Carolina 29650 |
| Jameson Memorial Hospital - North Campus | New Castle, Pennsylvania 16105 |
| Holy Cross Hospital | Silver Spring, Maryland 20910 |
| Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
| CCOP - Kansas City | Prairie Village, Kansas 66208 |
| Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
| Providence Newberg Medical Center | Newberg, Oregon 97132 |
| Willamette Falls Hospital | Oregon City, Oregon 97045 |
| Island Hospital Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
| Highline Medical Center Cancer Center | Burien, Washington 98166 |
| Upper Chesapeake Medical Center | Bel Air, Maryland 21014 |
| Southern Ohio Medical Center Cancer Center | Portsmouth, Ohio 45662 |
| Alle-Kiski Medical Center | Natrona Heights, Pennsylvania 15065 |
| Swedish Medical Center - Issaquah Campus | Issaquah, Washington 98029 |
| Forbes Regional Hospital | Monroeville, Pennsylvania 15146 |
| Zangmeister Center | Columbus, Ohio 43219 |
