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Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Sentinel node identification

Outcome Time Frame:

at time of procedure

Safety Issue:

No

Principal Investigator

Thomas A. D'Amico, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

CDR0000378197

NCT ID:

NCT00089310

Start Date:

September 2004

Completion Date:

April 2009

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Beebe Medical CenterLewes, Delaware  19958
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043