NCT00003901

Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery

A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,310 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment. PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

Detailed description

OBJECTIVES: * Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer. * Determine the relationship between these indicators and conventional histology. * Model survival considering the indicators and other patient attributes that are of prime prognostic significance. * Determine the relationships between the indicators and the site of first recurrence in these patients. * Determine the prevalence of the indicators in these patients. * Determine the relationships between the indicators and disease free survival in these patients.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
OTHER	immunohistochemistry staining method
PROCEDURE	biopsy
PROCEDURE	surgery

Timeline

• Start date: 1999-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2003-01-27
• Last updated: 2017-02-16
• Results posted: 2017-02-16

Locations

58 sites across 2 countries: United States, Canada