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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
Open (Enrolling)
Both
Lung Cancer

Thank you

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 InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
CCOP - ColumbusColumbus, Ohio  43206
CCOP - GreenvilleGreenville, South Carolina  29615
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
CCOP - NorthwestTacoma, Washington  98405-0986
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
SUNY Upstate Medical University HospitalSyracuse, New York  13210
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Veterans Affairs Medical Center - Loma Linda (Pettis)Loma Linda, California  92357
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Minor and James Medical, PLLCSeattle, Washington  98104
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Evanston HospitalEvanston, Illinois  60201-1781
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Grant Medical Center Cancer CareColumbus, Ohio  43215
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
St. Joseph Cancer CenterBellingham, Washington  98225
Providence Centralia HospitalCentralia, Washington  98531-9027
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
St. Vincent's Medical CenterBridgeport, Connecticut  06606
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Duke Cancer InstituteDurham, North Carolina  27710
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Parvin Radiation OncologyKansas City, Missouri  64116
Veterans Affairs Medical Center - IndianapolisIndianapolis, Indiana  46202
Valley Hospital - RidgewoodRidgewood, New Jersey  07450
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Cancer Centers of the Carolinas - EasleyEasley, South Carolina  29640
Cancer Centers of the Carolinas - Greer Radiation OncologyGreer, South Carolina  29650
Jameson Memorial Hospital - North CampusNew Castle, Pennsylvania  16105
Holy Cross HospitalSilver Spring, Maryland  20910
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
CCOP - Kansas CityPrairie Village, Kansas  66208
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Willamette Falls HospitalOregon City, Oregon  97045
Island Hospital Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center Cancer CenterBurien, Washington  98166
Upper Chesapeake Medical CenterBel Air, Maryland  21014
Southern Ohio Medical Center Cancer CenterPortsmouth, Ohio  45662
Alle-Kiski Medical CenterNatrona Heights, Pennsylvania  15065
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029
Forbes Regional HospitalMonroeville, Pennsylvania  15146
Zangmeister CenterColumbus, Ohio  43219