Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000217000
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
17/03/2010
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results information initially provided
7/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Scientific title
A study of patient with small peripheral resectable non-small cell lung cancer (<2cm) to determine whether sublobar resection results in the same disease-free survival as lobectomy
Secondary ID [1] 1483 0
CALGB-140503
Issued by Cancer and Leukemia Group B
Secondary ID [2] 1484 0
ECOG-40503
Issued by Eastern Co-operative Oncology Group
Universal Trial Number (UTN)
NCT00499330
Issued by the US National Institutes of Health
Trial acronym
WORLD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 256966 0
Condition category
Condition code
Cancer 257109 257109 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sublobar resection (removal of less than one lobe of lung) consists of either segmentectomy or wedge resection of lung.
Segmentectomy refers to identifying and cutting the specific blood supply and airway to the particular segment of the lobe of lung containing the lung cancer. The procedure takes 2-3 hours.
Wedge resection refers to calculating a margin of normal tissue that allows full removal of the cancer, then removing that from the lobe of the lung using a cutting stapler. The procedure takes about one hour.
Sublobar resection can be done through a thoracotomy (large cut on the side of the chest) or with Video-Assisted Thoracic Surgery (VATS), which uses small incisions and a telescope to achieve the same internal operation.
Intervention code [1] 256143 0
Treatment: Surgery
Comparator / control treatment
Lobectomy refers to identifying and cutting the specific blood supply and airway to the lobe of lung containing the lung cancer. The procedure takes 2-3 hours.
Lobectomy can be done through a thoracotomy (large cut on the side of the chest) or with Video-Assisted Thoracic Surgery (VATS), which uses small incisions and a telescope to achieve the same internal operation.
Control group
Active

Outcomes
Primary outcome [1] 258004 0
Disease-free survival as assessed by chest X-rays and computed tomography (CT Scan) of the chest. Additional investigations such as positron emission tomography (PET scan) and biopsies will also be used if clinically indicated.
Timepoint [1] 258004 0
Quarterly up to two years then annually up to five years post-surgery
Secondary outcome [1] 263558 0
Overall survival as determined by physical examination
Timepoint [1] 263558 0
Quarterly up to two years then annually up to five years post-surgery
Secondary outcome [2] 263559 0
Rate of loco-regional and systemic recurrence as assessed by chest X-rays and computed tomography (CT Scan) of the chest. Additional investigations such as positron emission tomography (PET scan) and biopsies will also be used if clinically indicated.
Timepoint [2] 263559 0
Quarterly up to two years then annually up to five years post-surgery
Secondary outcome [3] 263560 0
Pulmonary function as measured by expiratory flow rate
Timepoint [3] 263560 0
Up to 1 month prior to surgery and at 6 months post-surgery

Eligibility
Key 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 computed tomography (CT scan) AND Center of the tumor must be located in the outer third of the lung in either the transverse, coronal, or sagittal plan AND Tumor location must be suitable for either lobar or sublobar resection (wedge resection or segmentectomy) AND No pure ground opacities or pathologically confirmed N1 or N2 disease
Intraoperative criteria - Histologically confirmed NSCLC AND 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 up to 6 weeks preoperatively by mediastinoscopy, endobronchial ultrasound (EBUS), and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of locally advanced or metastatic disease
Prior chemotherapy or radiotherapy for this malignancy
Eastern Cooperative Oncology Group (ECOG) Performance status > 2
Any other malignancy within the past 3 years except for non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix

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)
Concealed allocation until intra-operative randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Centralized computer generated sequence via Duke University Durham, North Carolina, USA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Australian sites were no longer included as part of the Alliance for clinical trials in Oncology (USA) and were shut down prematurely.
Date of first participant enrolment
Anticipated
25/02/2010
Actual
5/02/2010
Date of last participant enrolment
Anticipated
30/12/2016
Actual
2/12/2013
Date of last data collection
Anticipated
3/12/2018
Actual
11/11/2020
Sample size
Target
60
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 256646 0
Other Collaborative groups
Name [1] 256646 0
American College of Surgeons Oncology Group (ACOSOG)
Country [1] 256646 0
United States of America
Primary sponsor type
Government body
Name
The National Cancer Institute
Address
Building 31, Room 11A-16
9000 Rockville Pike
Bethesda, MD 20892
Country
United States of America
Secondary sponsor category [1] 255933 0
Government body
Name [1] 255933 0
Cancer Trials Support Unit of the National Cancer Institute (CTSU)
Address [1] 255933 0
Cancer Trials Support Unit
The National Cancer Institute
Building 31, Room 11A-16
9000 Rockville Pike
Bethesda, MD 20892
Country [1] 255933 0
United States of America
Other collaborator category [1] 1153 0
Other Collaborative groups
Name [1] 1153 0
Cancer and Leukemia Group B (CALGB)
Address [1] 1153 0
CALGB Central Office
230 West Monroe, Suite 2050
Chicago, IL 60606
Country [1] 1153 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258670 0
St Vincent's Hospital Human Research Ethics Committee (HREC-A)
Ethics committee address [1] 258670 0
Research & Grants Unit
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 258670 0
Australia
Date submitted for ethics approval [1] 258670 0
Approval date [1] 258670 0
19/02/2010
Ethics approval number [1] 258670 0
09/0137

Summary
Brief summary
Lobectomy (or removal of one of the lobes of the lung) is the standard operation for lung cancer that is amenable to surgery. For patients with insufficient breathing reserve, a sublobar resection (segmentectomy or wedge resection) can be offered as it involves the removal of much less lung. The question that surgeons do not know the answer to is how much lung needs to be removed to completely clear around a small lung cancer at the edge of the lung. It may or may not require the removal of the whole lobe, and this study will determine whether a sublobar resection is as good at controlling the cancer as a lobectomy. This is similar to studies in breast cancer that showed that the whole breast did bot have to be removed to control a small breast cancer.
Trial website
http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=555324&version=patient
Trial related presentations / publications
Nil results yet
Public notes

Contacts
Principal investigator
Name 30932 0
A/Prof Gavin M Wright
Address 30932 0
Director of Surgical Oncology
St Vincent's Hospital
55 Victoria Parade
Fitzroy VIC 3065
Country 30932 0
Australia
Phone 30932 0
+61 3 94192477
Fax 30932 0
+61 3 94171694
Email 30932 0
[email protected]
Contact person for public queries
Name 14179 0
Ms Ms Jane Mack
Address 14179 0
Cardiothoracic Research Office
4th Floor
Inpatient Services Building
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 14179 0
Australia
Phone 14179 0
+61 3 9288 4615
Fax 14179 0
+61 3 9288 4616
Email 14179 0
[email protected]
Contact person for scientific queries
Name 5107 0
A/Prof Gavin M Wright
Address 5107 0
Director of Surgical Oncology
St Vincent's Hospital
5th Floor
55 Victoria Parade
Fitzroy VIC 3065
Country 5107 0
Australia
Phone 5107 0
+61 3 9419 2477
Fax 5107 0
+61 3 9417 1694
Email 5107 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.