NCT00089310CompletedNot Applicable
Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer
Alliance for Clinical Trials in Oncology12 sites in 1 country46 target enrollmentStarted: September 1, 2004Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46
- Locations
- 12
- Primary Endpoint
- Sentinel node identification
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with clinical stage I lung cancer for whom surgical resection is planned are eligible. Histologic confirmation of lung cancer is not required prior to registration or surgical exploration. Preoperative mediatinoscopy is allowed but not required in those patients with indications for mediatinoscopy. It is preferred that that mediatinoscopy be done at a different setting (prior to registration), but the procedure may be done at the same setting as the lobectomy.
- •No prior therapy for this diagnosis.
- •No prior treatment with mediastinal radiation therapy.
- •Age ≥ 18 years of age.
- •ECOG performance status: 0-2.
Exclusion Criteria
- Not provided
Arms & Interventions
Sentinal node mapping
Experimental
Intervention: technetium-99 (Radiation)
Outcomes
Primary Outcomes
Sentinel node identification
Time Frame: at time of procedure
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (12)
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