Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborators:	National Cancer Institute (NCI) Radiation Therapy Oncology Group American College of Surgeons Southwest Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00499330

Purpose

RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Procedure: therapeutic thoracoscopy Procedure: videothoracoscopy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Rate of loco-regional and systemic recurrence [ Designated as safety issue: No ]
Pulmonary function as measured by expiratory flow rate 6 months postoperatively [ Designated as safety issue: No ]

Estimated Enrollment:	1258
Study Start Date:	June 2007
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm I Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS).	Procedure: therapeutic thoracoscopy Patients undergo lobectomy, wedge resection, or anatomical segmentectomy by thoracoscopic surgery Procedure: videothoracoscopy Patients undergo lobectomy, wedge resection, or anatomical segmentectomy by video-assisted thoracoscopic surgery
Experimental: Arm II Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS.	Procedure: therapeutic thoracoscopy Patients undergo lobectomy, wedge resection, or anatomical segmentectomy by thoracoscopic surgery Procedure: videothoracoscopy Patients undergo lobectomy, wedge resection, or anatomical segmentectomy by video-assisted thoracoscopic surgery

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499330

Show 136 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

American College of Surgeons

Southwest Oncology Group

Investigators

Study Chair:	Nasser K. Altorki, MD	Weill Medical College of Cornell University
Study Chair:	Harvey I. Pass, MD	New York University School of Medicine
Study Chair:	Daniel L. Miller, MD	Emory University
Study Chair:	Kemp H. Kernstine, MD, PhD	Holden Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00499330 History of Changes
Other Study ID Numbers:	CDR0000555324, CALGB-140503, ECOG-40503
Study First Received:	July 10, 2007
Last Updated:	February 7, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012