Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Lung Cancer

Treatments: Genetic: reverse transcriptase-polymerase chain reaction; Other: immunohistochemistry staining method

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00003006

CALGB-9761

CDR0000065576 (Registry Identifier)

CLB-9761

U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors plan better treatment for non-small cell lung cancer.

PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated.

Full description

OBJECTIVES:

• Determine whether the presence of occult micrometastases (OM) detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR) in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer.
• Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry (staining for cytokeratins and the CEA glycoprotein) or RT-PCR (to detect CEA mRNA) in these patients.
• Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients.
• Determine the relationship between tumor size (or T-stage) and the presence of OM detected by immunohistochemistry or RT-PCR in these patients.
• Determine the relationship between the presence of OM and disease-free survival in these patients.
• Determine the relationship between the site of OM and incidence of recurrence, site of recurrence, and survival of these patients.

OUTLINE: At the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction.

Patients are followed every 6 months for 5 years.

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Clinical stage I proven or suspected new non-small cell lung carcinoma T1 or T2 primary N1 or N2 lymph nodes <1cm on CT or negative mediastinoscopy
• ≥ 5 years since prior chemo or XRT; no prior mediastinal or chest XRT.
• ≥ 18 years of age
• No history of previous lung cancer or concomitant malignancy

Trial design

501 participants in 1 patient group

Group 1

Description:

At the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction.

Treatment:

Genetic: reverse transcriptase-polymerase chain reaction

Other: immunohistochemistry staining method