Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Cancer and Leukemia Group B

ClinicalTrials.gov Identifier:

NCT00089310

First received: August 4, 2004

Last updated: April 6, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2004

Last Updated Date

April 6, 2011

Start Date ^ICMJE

September 2004

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sentinel node identification [ Time Frame: at time of procedure ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00089310 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer

Official Title ^ICMJE

Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer

Brief Summary

RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes.

PURPOSE: This clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery for stage I non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

Determine the feasibility and accuracy of intraoperative sentinel lymph node mapping using technetium Tc 99 sulfur colloid in patients with stage I non-small cell lung cancer.
Determine the percentage of patients in which at least 1 positive sentinel lymph node is identified using this procedure.
Determine the percentage of patients undergoing this procedure who are found to have positive sentinel lymph nodes with no metastases in other intrathoracic lymph nodes.

Secondary

Determine the percentage of patients undergoing this procedure whose disease stage is upgraded due to detection of micrometastases in sentinel lymph nodes.
Correlate the presence of micrometastases in sentinel lymph nodes with survival in patients undergoing this procedure.
Determine the percentage of patients undergoing this procedure with "skip metastases" pattern (NZ) sentinel lymph nodes.

OUTLINE: This is a multicenter study.

Patients receive an intraoperative intratumoral injection of technetium Tc 99 sulfur colloid. At least 10 minutes later, patients undergo sentinel lymph node mapping using a gamma probe. Patients then undergo sentinel lymph node dissection and tumor resection. Pathology assays are performed using sentinel lymph node tissue, including hematoxylin and eosin staining, serial sections, and immunohistochemistry using the AE1/AE3/PCK2b cytokeratin antibody.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 57-150 patients will be accrued for this study within 2 years.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Radiation: technetium-99

0.25 mCi in 4 equal doses

Study Arm (s)

Experimental: Sentinal node mapping

Intervention: Radiation: technetium-99

Publications *

Liptay MJ, D'amico TA, Nwogu C, Demmy TL, Wang XF, Gu L, Litle VR, Swanson SJ, Kohman LJ; Thoracic Surgery Subcommittee of the Cancer and Leukemia Group B. Intraoperative sentinel node mapping with technitium-99 in lung cancer: results of CALGB 140203 multicenter phase II trial. J Thorac Oncol. 2009 Feb;4(2):198-202.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of non-small cell lung cancer
- Clinical stage I disease
- Resectable disease
Planned surgical resection of lung cancer

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

No prior mediastinal radiotherapy

Surgery

See Disease Characteristics

Other

No prior therapy for the malignancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00089310

Other Study ID Numbers ^ICMJE

CDR0000378197, U10CA031946, CALGB-140203

Has Data Monitoring Committee

Responsible Party

Monica M Bertagnolli, Cancer and Leukemia Group B

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Thomas A. D'Amico, MD

Duke University

Information Provided By

Cancer and Leukemia Group B

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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