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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
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer



- 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).


- 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

- 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

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


- 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

- No evidence of locally advanced or metastatic disease


- 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


- No prior chemotherapy or radiotherapy for this malignancy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:


Principal Investigator

Nasser K. Altorki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University



Study ID:




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



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SUNY Upstate Medical University Hospital Syracuse, New York  13210
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Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Olympic Hematology and Oncology Bremerton, Washington  98310
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University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
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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
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Providence St. Vincent Medical Center Portland, Oregon  97225
Minor and James Medical, PLLC Seattle, Washington  98104
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UAB Comprehensive Cancer Center Birmingham, Alabama  35294
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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
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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
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Auburn Regional Center for Cancer Care Auburn, Washington  98002
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St. Vincent's Medical Center Bridgeport, Connecticut  06606
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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
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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
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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