Know Cancer

or
forgot password

Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma


OBJECTIVES:

- Compare whether a complete mediastinal lymph node dissection versus mediastinal lymph
node sampling improves overall survival of patients with N0 or non-hilar N1 non-small
cell lung cancer undergoing resection.

- Compare these two methods with reference to identification of occult mediastinal lymph
node involvement.

- Compare the effect of these two methods on operative time and duration of postoperative
complications, including chest tube drainage and length of hospitalization for these
patients.

- Compare the effect of these two methods on local recurrence free survival and local
regional recurrence free survival of these patients.

OUTLINE: This is a randomized study.

Patients undergo lymph node sampling from multiple sites inside the chest. Patients with
negative lymph nodes are randomized to 1 of 2 treatment arms.

- Arm I (Mediastinal Lymph Node Sampling): No more lymph nodes are removed. Patients
undergo pulmonary resection.

- Arm II (Mediastinal Lymph Node Dissection): Patients undergo removal of nearly all of
the lymph nodes from the central part of the chest between the lungs, followed by
pulmonary resection.

Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter
until death.

PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study
over 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Biopsy proven or suspected, clinically resectable stage I or II (T1 or T2, N0 or
non-hilar N1, M0) non-small cell carcinoma of the lung (NSCLC)

- Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma

- If tissue diagnosis not established preoperatively, must be established
intraoperatively prior to registration/randomization

- If preoperative mediastinoscopy has been performed, hilar lymph nodes must be
certified to be less than 1 cm in the short axis diameter by preoperative CT scan,
and no N2 disease found at mediastinoscopy

- If preoperative mediastinoscopy has not been performed, all lymph nodes in the hilum
and mediastinum must measure less than 1 cm in the short axis diameter on
preoperative CT scan

- Candidate for complete resection via pneumonectomy, bilobectomy, lobectomy, or
anatomic segmentectomy with or without sleeve resection

- Planned wedge resection only not eligible

- All sampled nodes must be negative by frozen section assessment

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

Other:

- Medically fit for surgery

- No prior malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix, and deemed to be at low
risk for recurrence from prior curatively treated malignancies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for NSCLC

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for NSCLC

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mark S. Allen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066988

NCT ID:

NCT00003831

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
University of Chicago Cancer Research CenterChicago, Illinois  60637
Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Loyola University Medical CenterMaywood, Illinois  60153
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
LDS HospitalSalt Lake City, Utah  84143
Massey Cancer CenterRichmond, Virginia  23298-0037
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Medical Center of Central GeorgiaMacon, Georgia  31201
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Holmes Regional Medical CenterMelbourne, Florida  32901-3276
Central Baptist HospitalLexington, Kentucky  40503
Valley HospitalRidgewood, New Jersey  07450
Emory University School of MedicineAtlanta, Georgia  30322
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
Jackson Memorial HospitalMiami, Florida  33136
William Beaumont Hospital - Royal OakRoyal Oak, Michigan  48073-6769
Earle A. Chiles Research Institute at Providence Portland Medical CenterPortland, Oregon  97213-2967
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104
Veterans Affairs Medical Center - GainesvilleGainesville, Florida  32608-1197
Edward Hospital Cancer CenterNaperville, Illinois  60540
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
UPMC St. MargaretPittsburgh, Pennsylvania  15215
Veterans Affairs Medical Center - OmahaOmaha, Nebraska  68105
Presbyterian-University HospitalPittsburgh, Pennsylvania  15213
Louis Busch Hager Cancer Center at Mary Imogene Bassett HospitalCooperstown, New York  13326
Huntington Cancer Center at Huntington HospitalPasadena, California  91105
Shands Cancer Center at the University of FloridaGainesville, Florida  32610-0342
Alexian Brothers Medical CenterElk Grove Village, Illinois  60007
St. John's HospitalSpringfield, Illinois  62701
Jewish HospitalLouisville, Kentucky  40202-1886
Medical Center of Southwest LouisianaLafayette, Louisiana  70506
Rhode Island HospitalBoston, Massachusetts  02114-2620
St. Luke's HospitalDuluth, Minnesota  55805-2193
Creighton University School of MedicineOmaha, Nebraska  68131
Englewood Hospital Oncology ProgramEnglewood, New Jersey  07631
Trinity HospitalMinot, North Dakota  58701
Tri-Health Good Samaritan HospitalCincinnati, Ohio  45220
Westmoreland Regional HospitalGreensburg, Pennsylvania  15601-2282
Jameson Memorial HospitalNew Castle, Pennsylvania  16105
Temple University HospitalPhiladelphia, Pennsylvania  19140
St. Clair Memorial HospitalPittsburgh, Pennsylvania  15243-1899
University of Pittsburg Medical Center - Shadyside HospitalPittsburgh, Pennsylvania  15213-2582
Saint Thomas HospitalNashville, Tennessee  37205