Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002624




Registration number
NCT00002624
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
14/07/2016

Titles & IDs
Public title
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
Scientific title
VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
Secondary ID [1] 0 0
U10CA031946
Secondary ID [2] 0 0
CALGB-9335
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
Experimental: Radiotherapy + surgery - Patients begin radiotherapy 2-8 weeks postoperatively. Patients with complete resection undergo radiotherapy 5 days a week for 5.6 weeks. Patients with incomplete resection undergo radiotherapy 5 days a week for 6.6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
Timepoint [1] 0 0
Up to 10 years
Primary outcome [2] 0 0
Determine the incidence of locoregional recurrence in patients treated with this regimen
Timepoint [2] 0 0
Up to 10 years
Primary outcome [3] 0 0
Determine the overall and disease-free survival
Timepoint [3] 0 0
Up to 10 years
Primary outcome [4] 0 0
Determine the short- and long-term complications associated with VAR in these patients
Timepoint [4] 0 0
Up to 10 years
Primary outcome [5] 0 0
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Timepoint [5] 0 0
Up to 10 years
Primary outcome [6] 0 0
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
Timepoint [6] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Known or suspected, single, peripheral, stage T1 N0 M0 lung tumor

* Tumor must not be identifiable by bronchoscopy

* Bronchoscopically visible cancer or bronchial distortions considered related to tumor
* Positive cytology by bronchoscopy allowed if no gross abnormality visible
* Mediastinoscopy required for nodes greater than 1 cm
* No pleural effusions
* No metastatic or N2 disease on CT scan
* Lesion must be accessible for video-assisted thoracoscopic wedge resection
* High cardiopulmonary risk for thoracotomy with at least 1 of the following criteria:

* FEV1 less than 40% predicted
* DLCO less than 50% predicted
* Supplemental oxygen requirement
* Chronic PaCO2 greater than 45 mm Hg
* Maximum oxygen consumption (VO2 max) less than 15 mL/kg/min
* Patients who appear at high risk for non-pulmonary reasons (e.g., patients who are elderly or with renal or cardiac failure) may be eligible only if VO2 max or other criteria above are met
* Eligible for radiotherapy after completion of wedge resection if histologic documentation of non-small cell lung cancer, including any of the following subtypes:

* Squamous cell carcinoma
* Adenocarcinoma
* Bronchoalveolar cell
* Large cell anaplastic carcinoma
* Cytology from bronchial washings and transthoracic needle aspiration not acceptable

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* 0-2

Other:

* No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Weight loss no greater than 10% within the past 6 months

PRIOR CONCURRENT THERAPY:

Radiotherapy

* No prior thoracic irradiation
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
NA
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/1994
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2005
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Peru
State/province [9] 0 0
Lima
Country [10] 0 0
Puerto Rico
State/province [10] 0 0
San Juan

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hani Shennib, MD
Address 0 0
Montreal General Hospital
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00002624