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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00499330




Registration number
NCT00499330
Ethics application status
Date submitted
10/07/2007
Date registered
11/07/2007
Date last updated
25/03/2024

Titles & IDs
Public title
Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Scientific title
A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (= 2 cm) Peripheral Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
CALGB-140503
Secondary ID [2] 0 0
CALGB 140503
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - lobectomy
Treatment: Surgery - segmentectomy or wedge resection

Other: Arm A - Patients undergo a standard operation for lung cancer called a lobectomy.

Experimental: Arm B - Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.


Treatment: Surgery: lobectomy


Treatment: Surgery: segmentectomy or wedge resection
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
disease-free survival
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [1] 0 0
overall survival
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [2] 0 0
rate of loco-regional and systemic recurrence
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [3] 0 0
pulmonary function as measured by expiratory flow rate 6 months postoperatively
Timepoint [3] 0 0
at 6 months

Eligibility
Key inclusion criteria
Pre-registration Eligibility Criteria:

1. Peripheral lung nodule = 2 cm on preoperative CT scan and presumed to be lung cancer.
The center of the tumor, as seen on CT, must be located in the outer third of the lung
in either the transverse, coronal or sagittal plane. Patients with pure ground glass
opacities or pathologically confirmed N1 or N2 disease are not eligible.

2. The tumor location must be suitable for either lobar or sublobar resection (wedge or
segment).

3. ECOG performance status of 0-2.

4. No prior malignancy within 3 years other than non-melanoma skin cancer, superficial
bladder cancer, or CIS of the cervix.

5. No prior chemotherapy or radiation therapy for this malignancy.

6. No evidence of locally advanced or metastatic disease.

7. Age = 18 years

Intra-operative Randomization Eligibility Criteria:

1. Histologic confirmation of NSCLC (if not already obtained)

2. Confirmation of N0 status by frozen section examination. Right sided tumors require
that node levels 4, 7, and 10 be sampled and diagnosed as negative on frozen section.
Left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed
as negative on frozen section. 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 VATS exploration. Nodes previously sampled by mediastinoscopy (or EBUS
and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical
procedure (thoracotomy or VATS) do not need to be resampled.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
701
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Saint Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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Wisconsin
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Wyoming
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Alliance for Clinical Trials in Oncology
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00499330
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nasser Altorki, MD
Address 0 0
Weill Medical College of Cornell University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00499330