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

Lung Cancer Clinical Trial

Official title:

Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003006
• Other study ID #: CALGB-9761
• Secondary ID: U10CA031946CLB-9
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: June 28, 2016
• Start date: May 1997
• Est. completion date: June 2010

Study information

• Verified date: June 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: June 2010
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• reverse transcriptase-polymerase chain reaction

Other:
• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	State University of New York - Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

D'Cunha J, Corfits AL, Herndon JE 2nd, Kern JA, Kohman LJ, Patterson GA, Kratzke RA, Maddaus MA. Molecular staging of lung cancer: real-time polymerase chain reaction estimation of lymph node micrometastatic tumor cell burden in stage I non-small cell lun — View Citation

D'Cunha J, Herndon JE 2nd, Herzan DL, Patterson GA, Kohman LJ, Harpole DH, Kernstine KH, Kern JA, Green MR, Maddaus MA, Kratzke RA; Cancer and Leukemia Group B. Poor correspondence between clinical and pathologic staging in stage 1 non-small cell lung can — View Citation

D'Cunha J, Herndon JL, Herzan DL, et al.: Poor correlation between clinical and pathological staging in stage I non-small cell lung cancer: results from CALGB 9761, a prospective trial. [Abstract] Proceedings of the American Society of Clinical Oncology 2

Maddaus MA, Wang X, Vollmer RT, et al.: CALGB 9761: a prospective analysis of IHC and PCR based detection of occult metastatic disease in stage I NSCLC. [Abstract] J Clin Oncol 24 (Suppl 18): A-7030, 371s, 2006.

Potti A, Mukherjee S, Petersen R, Dressman HK, Bild A, Koontz J, Kratzke R, Watson MA, Kelley M, Ginsburg GS, West M, Harpole DH Jr, Nevins JR. A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer. N Engl J Med. 2006 Aug 10;355(6):570-80. Erratum in: N Engl J Med. 2007 Jan 11;356(2):201-2. Retraction in: Potti A, Mukherjee S, Petersen R, Dressman HK, Bild A, Koontz J, Kratzke R, Watson MA, Kelley M, Ginsburg GS, West M, Harpole DH Jr, Nevins JR. N Engl J Med. 2011 Mar 24;364(12):1176. — View Citation

Vollmer RT, Herndon JE 2nd, D'Cunha J, Abraham NZ, Solberg J, Fatourechi M, Maruska A, Kern JA, Green MR, Kratzke RA, Maddaus MA; Cancer and Leukemia Group B Trial 9761. Immunohistochemical detection of occult lymph node metastases in non-small cell lung — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		up to 5 years	No