A prospective multi-institutional study in resectable lung cancer of the prognostic significance and incidence of occult distant disease

Originating Group

ACS-OG Z0040

P.I.: Dr. Robbin Cohen 322-442-5849

Objectives

This study will gather data on three indicators of occult metastases in patients with resectable non-small cell lung cancer: cytology examination of pleural lavage, immunohistochemistry assay of micrometastatic depostis within lymph nodes, and immunohistochemistry assay of micormetastases in rib bone marrow.

Primary objective: To model the relationships between each of these indicators of occult micrometastases and overall survival. Secondary objectives:

1. To study the relationships between the indicators and conventional histology.
2. To model overall survival considering the indicators and other patient attributes which are of prognositc significance.
3. To study the relationships between the indicators and the site of first recurrence.
4. To estimate the prevalence of the indicators.
5. To model the relationships between the indicators and disease-free survival.

Eligibility

1. Patient must have clinically resectable, non-small cell carcinoma of the lung and be clinical stage I, IIa, IIb, or IIIa.
2. If preoperative mediastinoscopy has been performed, a patient with N1 and N2 disease is eligible. A patient with N3 disease is not eligible.
3. Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, through the adrenal glands.
4. Patients must be medically fit for surgery and be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy, with or without sleeve resection.
5. Patient must not have evidence of pleural effusion by physical assessment, lateral cxr, or by chest ct scan.
6. Patient must not have had ipsilateral thoracotomy, or thoracoscopy within the past 5 years.
7. Patient's performance status must be less than 3 on the ECOG/Zubrod scale
8. Patient must not have received prior chemotherapy or radiotherapy for this cancer.
9. Patient must be 18 yrs or older and must sign a study-specific consent form prior to study entry.
10. A cancer survivor is eligible providing the following criteria are met: (a) the patient has undergone potentially curative therapy for all prior malignancies, and (b) there has been no evidence of any prior malignancies for the at least 5 years.

Schema

Comments

activated 10/99

target accrual 1200 patients

accrual 0/1200 as of 10/99