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

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Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2009
Sponsors and Collaborators: Cancer and Leukemia Group B
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: thoracoscopic surgery
Procedure: videothoracoscopy
Phase III




MedlinePlus related topics: Cancer Lung Cancer Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer


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: 1297
Study Start Date: June 2007
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Active Comparator
Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS). Procedure: thoracoscopic surgery
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
Arm II: Experimental
Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS. Procedure: thoracoscopic surgery
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 &#8805; 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 every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 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 &#8804; 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 or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration* NOTE: *Nodes previously sampled by mediastinoscopy either immediately prior to 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 5 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 114 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


Clinical trial summary from the National Cancer Institute's PDQ® database
Featured trial article

Study ID Numbers: CDR0000555324, CALGB-140503, ECOG-40503
Study First Received: July 10, 2007
Last Updated: February 7, 2009
ClinicalTrials.gov Identifier: NCT00499330 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I 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



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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