Lung CancerPhase 3NCT00003901

Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery

A Phase 3 study testing immunohistochemistry staining method, biopsy and surgery in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment. PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that… 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?: immunohistochemistry staining method, biopsy and surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,310 participants
Where: 58 sitesin 2 countries
Study dates: Jul 1999to Oct 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Patient must be ≥ 18 years old.
Patient must have ECOG/Zubrod status < 3.
Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.
Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.
Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.

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Patient must be medically fit for surgery.
Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
Patient must be available for follow-up.
If the patient is a survivor of a prior cancer, all of the following criteria must apply:
Patient has undergone potentially curative therapy for all prior malignancies,
No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Who cannot join

Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.
Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
Patient has received prior chemotherapy or radiotherapy for this cancer.
Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
Patient for whom the surgeon plans to perform only a wedge resection for treatment.

Trial locations and contacts

58 sites in 2 countries.

Country

City, postcode or hospital

58 sites in 2 countries

United States56 sites

Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0558
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Colorado Health Sciences Center - Denver
Denver, Colorado, 80262
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
McLaren Regional Cancer Center
Flint, Michigan, 48432
Hurley Medical Center
Flint, Michigan, 48503
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601-2282
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1062
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jewish Hospital
Louisville, Kentucky, 40202-1886
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-7375
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Providence Cancer Center
Mobile, Alabama, 36608
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
Cottonwood Hospital Medical Center
Murray, Utah, 84107
Saint Thomas Hospital
Nashville, Tennessee, 37205
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-6838
Jameson Memorial Hospital
New Castle, Pennsylvania, 16105
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, 68105
Creighton University School of Medicine
Omaha, Nebraska, 68131
Huntington Cancer Center at Huntington Hospital
Pasadena, California, 91105
Abramson Cancer Center of the University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, 15243-1899
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
University of California Davis Cancer Center
Sacramento, California, 95817
LDS Hospital
Salt Lake City, Utah, 84143
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6310
Cancer Institute at St. John's Hospital
Springfield, Illinois, 62701
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Siteman Cancer Center
St Louis, Missouri, 63110
Bayfront Medical Center
St. Petersburg, Florida, 33701
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, 11794-8191
University Hospital at State University of New York - Upstate Medical University
Syracuse, New York, 13210
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada2 sites

Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Toronto General Hospital
Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.

PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.
Determine the relationship between these indicators and conventional histology.
Model survival considering the indicators and other patient attributes that are of prime prognostic significance.
Determine the relationships between the indicators and the site of first recurrence in these patients.
Determine the prevalence of the indicators in these patients.
Determine the relationships between the indicators and disease free survival in these patients.

Conditions: Lung Cancer
Being tested: immunohistochemistry staining method, biopsy, surgery
Keywords: stage I non-small cell lung cancer, stage II non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

immunohistochemistry staining methodOther
biopsyProcedure or surgery
surgeryProcedure or surgery

Study groups in NCT00003901
Study group	Role	What they receive
Surgery	Experimental	All patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed. Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years. Receives: Other: immunohistochemistry staining method; Procedure: biopsy; Procedure: surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival in Lymph Nodes Examined Patients
Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Measured: Up to 5 years
Overall Survival in Bone Marrow Examined Patients
Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Measured: Up to 5 years

Secondary outcomes (2)

Disease-Free Survival in Lymph Nodes Examined Patients
Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Measured: Up to 5 years
Disease-Free Survival in Bone Marrow Examined Patients
Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 1999Oct 2011

First posted27 Jan 2003 (estimated)
Study startJul 1999
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00003901
Sponsor's protocol ID: ACOSOG-Z0040
Other IDs: CDR0000067072
Status last verified: Dec 2016
First submitted: 1 Nov 1999
Last updated: 16 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rusch VW, Hawes D, Decker PA, Martin SE, Abati A, Landreneau RJ, Patterson GA, Inculet RI, Jones DR, Malthaner RA, Cohen RG, Ballman K, Putnam JB Jr, Cote RJ. Occult metastases in lymph nodes predict survival in resectable non-small-cell lung cancer: report of the ACOSOG Z0040 trial. J Clin Oncol. 2011 Nov 10;29(32):4313-9. doi: 10.1200/JCO.2011.35.2500. Epub 2011 Oct 11.
PubMed 21990404

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma
ClinicalTrials.gov ID: NCT00003901
Acronym / sponsor ID: ACOSOG-Z0040
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer, stage II non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,310 participants (actual)
Lead sponsor: Alliance for Clinical Trials in OncologyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jul 1999
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 27 Jan 2003 (estimated)
Results: Posted 16 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.

Detailed description

OBJECTIVES:

Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.
Determine the relationship between these indicators and conventional histology.
Model survival considering the indicators and other patient attributes that are of prime prognostic significance.
Determine the relationships between the indicators and the site of first recurrence in these patients.
Determine the prevalence of the indicators in these patients.
Determine the relationships between the indicators and disease free survival in these patients.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Surgery	Experimental	Other: immunohistochemistry staining method, Procedure: biopsy, Procedure: surgeryAll patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed. Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Patient must be ≥ 18 years old.
Patient must have ECOG/Zubrod status < 3.
Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.
Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.

Key exclusion criteria (5 listed)

Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.
Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
Patient has received prior chemotherapy or radiotherapy for this cancer.
Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
Patient for whom the surgeon plans to perform only a wedge resection for treatment.

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
immunohistochemistry staining method	Other	Surgery
biopsy	Procedure or surgery	Surgery
surgery	Procedure or surgery	Surgery

Primary outcome

Overall Survival in Lymph Nodes Examined Patients
Time frame: Up to 5 years
Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Overall Survival in Bone Marrow Examined Patients
Time frame: Up to 5 years
Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).

2 secondary outcomes

Disease-Free Survival in Lymph Nodes Examined Patients
Time frame: Up to 5 years
Disease-Free Survival in Bone Marrow Examined Patients
Time frame: Up to 5 years

Results and safety

Results posted to the registry on 16 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surgery	1,047	1,030

Primary outcome: Overall Survival in Lymph Nodes Examined Patients

Time frame: Up to 5 years. Median (95% Confidence Interval). Unit: years

Measure	OM Negative in Lymph Nodes n = 450	OM Positive in Lymph Nodes n = 130
Value	NA (NA to NA)	NA (NA to NA)

OM Negative in Lymph Nodes vs OM Positive in Lymph Nodes: Cox Proportional Hazard: 1.59 (95% CI 1.13 to 2.23), p = 0.007, Regression, Cox

Population analysed: Eligible participants with N0 non-small-cell lung cancer who had underwent pulmonary resection and were examined for OM

Primary outcome: Overall Survival in Bone Marrow Examined Patients

Time frame: Up to 5 years. Median (95% Confidence Interval). Unit: years

Measure	OM Negative in Bone Marrow n = 755	OM Positive in Bone Marrow n = 66
Value	NA (NA to NA)	NA (3.87 to NA)

OM Negative in Bone Marrow vs OM Positive in Bone Marrow: Cox Proportional Hazard: 1.03 (95% CI 0.69 to 1.54), p = 0.886, Regression, Cox

Population analysed: Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse events are collected on this trial. Adverse event would have only been collected for participant enrolled on both Z0030 and Z0040. Their adverse events are reported under Z0030 trial.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surgery	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21990404Rusch VW, Hawes D, Decker PA, Martin SE, Abati A, Landreneau RJ, Patterson GA, Inculet RI, Jones DR, Malthaner RA, Cohen RG, Ballman K, Putnam JB Jr, Cote RJ. Occult metastases in lymph nodes predict survival in resectable non-small-cell lung cancer: report of the ACOSOG Z0040 trial. J Clin Oncol. 2011 Nov 10;29(32):4313-9. doi: 10.1200/JCO.2011.35.2500. Epub 2011 Oct 11.

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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.

Robbin G. Cohen, MD study chair

University of Southern California

58 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing immunohistochemistry staining method, biopsy and surgery in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 58 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?

The sponsor lists 14 inclusion and 5 exclusion criteria. 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 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Overall Survival in Lymph Nodes Examined Patients (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003901, 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 16 Feb 2017.