Lung CancerNCT00003566
Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer
A study testing videothoracoscopy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 72 sites in 2 countries.
Trial summary
RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment. PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- videothoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 72 sitesin 2 countries
- Study dates
- Sep 1998to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Histologic Documentation: All patients must have histologic documentation of Stage IIIA non-small cell lung cancer on the basis of involved N2 nodes from a documented mediastinoscopy performed prior to induction therapy. Previously treated relapsed patients are not eligible.
- Prior Treatment: greater than or equal to 2 cycles of chemotherapy with or without radiotherapy (greater than or equal to 40 Gy) or radiotherapy alone (greater than or equal to 40 Gy) must be completed within 60 days of registration.
- No distant metastatic disease or local disease progression. Patients with responding or stable local disease are eligible. Those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible.
- No previous intrapleural surgery on the ipsilateral side.
- ECOG Performance Status: 0-2
Trial locations and contacts
72 sites in 2 countries.
72 sites in 2 countries
United States71 sites
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Cooper University Hospital
Camden, New Jersey, 08103
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
NorthEast Oncology Associates
Concord, North Carolina, 28025
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Elmhurst Hospital Center
Elmhurst, New York, 11373
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, 46885-5099
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
St. Mary's Medical Center
Huntington, West Virginia, 25701
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
CCOP - North Shore University Hospital
Manhasset, New York, 11030
North Shore University Hospital
Manhasset, New York, 11030
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Weill Medical College of Cornell University
New York, New York, 10021
Mount Sinai Medical Center, NY
New York, New York, 10029
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Florida Hospital Cancer Institute
Orlando, Florida, 32804
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
Saint Anthony Medical Center
Rockford, Illinois, 61108
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
Barnes-Jewish Hospital
St Louis, Missouri, 63110
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Puerto Rico1 site
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067
About this study
Official title: Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment.
PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer.
Read the detailed description
OUTLINE: The purpose of this study is to test the usefulness and safety of restaging the patient's cancer by a procedure called a thoracoscopy. Restaging is a process by which physicians measure the response of the patient to treatment. The primary and secondary objectives are described below.
OBJECTIVES:
Primary Objective:
- Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer.
Secondary Objectives:
- Evaluate the safety (morbidity and mortality) of pre-resectional, thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III (N2) NSCLC.
- Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy.
- Conditions
- Lung Cancer
- Being tested
- videothoracoscopy
- Keywords
- stage IIIA non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videothoracoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| video-thorascopy + surgery | Experimental | Patients will undergo ipsilateral video-thorascopic evaluation. Patients may undergo surgery at the discretion of the surgeon and treating physicians. Receives: Procedure: videothoracoscopy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1998
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Jaklitsch, MD, Study chair, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003566
- Sponsor's protocol ID
- CALGB-39803
- Other IDs
- U10CA031946, CLB-39803, CDR0000066632
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaklitsch MT, Gu L, Harpole DH, et al.: Prospective phase II trial of pre-resection thoracoscopic (VATS) restaging following neoadjuvant therapy for IIIA(N2) non-small cell lung cancer (NSCLC): results of CALGB 39803. [Abstract] J Clin Oncol 23 (Suppl 16): A-7065, 636s, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00003566
- Acronym / sponsor ID
- CALGB-39803
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1998
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment.
PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer.
Detailed description
OUTLINE: The purpose of this study is to test the usefulness and safety of restaging the patient's cancer by a procedure called a thoracoscopy. Restaging is a process by which physicians measure the response of the patient to treatment. The primary and secondary objectives are described below.
OBJECTIVES:
Primary Objective:
- Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer.
Secondary Objectives:
- Evaluate the safety (morbidity and mortality) of pre-resectional, thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III (N2) NSCLC.
- Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video-thorascopy + surgery | Experimental | Procedure: videothoracoscopyPatients will undergo ipsilateral video-thorascopic evaluation. Patients may undergo surgery at the discretion of the surgeon and treating physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| videothoracoscopy | Procedure or surgery | video-thorascopy + surgery |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Results publicationJaklitsch MT, Gu L, Harpole DH, et al.: Prospective phase II trial of pre-resection thoracoscopic (VATS) restaging following neoadjuvant therapy for IIIA(N2) non-small cell lung cancer (NSCLC): results of CALGB 39803. [Abstract] J Clin Oncol 23 (Suppl 16): A-7065, 636s, 2005.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Jaklitsch, MD study chair
Dana-Farber/Brigham and Women's Cancer Center
72 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videothoracoscopy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 72 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.