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Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study


Phase 2
N/A
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study


OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery
(VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with
small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the
rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these
patients. III. Describe the complications associated with this procedure. IV. Describe the
length of the operative procedure, duration of chest tube stay, and length of
hospitalization in this patient population. V. Describe the survival and failure-free
survival, over a 5-year period, in this patient population following this procedure.

OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3
small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as
well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible
to remove the lobe using the VATS approach, then 1 of the incisions is converted to a
standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then
every 6 months for the next 3 years.

PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Suspected or histologically documented non-small cell lung cancer
Solitary, peripheral lung lesion that is no greater than 3.0 cm No metastatic disease No
positive lymph nodes at mediastinoscopy At least 5 years since diagnosis of non-small cell
or small cell lung cancer

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Pulmonary: FEV1 at least 1.0 L or at least 50% of predicted Other: No significant comorbid
medical or psychiatric condition No other active malignancy other than nonmelanomatous
skin cancer

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Scott J. Swanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066795

NCT ID:

NCT00003692

Start Date:

December 1998

Completion Date:

March 2006

Related Keywords:

  • Lung Cancer
  • occult non-small cell lung cancer
  • stage I non-small cell lung cancer
  • stage 0 non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - ClevelandCleveland, Ohio  44106
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
CCOP - Sooner StateTulsa, Oklahoma  74136
Brigham and Women's HospitalBoston, Massachusetts  02115
Veterans Affairs Medical Center - GainsvilleGainesville, Florida  32608-1197
Veterans Affairs Medical Center - OmahaOmaha, Nebraska  68105