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

EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING

RATIONALE: Using new methods to examine sputum samples for the presence of cancer cells may detect lung cancer earlier.

PURPOSE: Screening trial to study the effectiveness of new methods of examining sputum samples to detect second primary lung cancer in patients with resected stage I non-small cell lung cancer.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: immunoenzyme technique; Procedure: study of high risk factors; Other: cytology specimen collection procedure

Detailed Description

OBJECTIVES: I. Evaluate whether immunostaining of induced sputum specimens improves the sensitivity and specificity of routine morphologic sputum surveillance to detect second primary lung cancer in patients with previously resected nonsmall cell lung cancer. II. Evaluate which patients are at risk of developing a second primary lung cancer by immunostaining specimens from patients with no morphologic atypia on routine Papanicolaou cytology. III. Make available archived sputum samples and bronchial washings for further analysis of new antibodies and techniques. IV. Evaluate whether analysis of elevations of relevant growth factors in bronchial lavage fluid from patients with positive immunostaining or morphologic atypia increases the accuracy of early detection. V. Evaluate whether quantitation of shed antigens in sputum increases the accuracy of early detection. VI. Evaluate whether the extent of airway obstruction, as measured by the forced expiratory volume, can predict an increased risk of developing lung cancer.

OUTLINE: Screening for Second Primary Lung Cancer. Annual sputum induction for Papanicolaou cytology and immunostaining (using monoclonal antibodies 624H12 and 703D4), with optional pulmonary function tests and fiberoptic bronchoscopy with bronchial washings.

PROJECTED ACCRUAL: 1,100 patients will be entered over 3 years. The sample size will be adjusted based on the rate of positive staining in the first 100 patients. Patients followed at uncertified centers are analyzed separately.

• Study Type: Interventional
• Enrollment (Estimated): 1100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Iowa
    • Des Moines, Iowa, United States, 10309-1016
      • CCOP - Iowa Oncology Research Association
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • CCOP - Northern New Jersey
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Allegheny University Hospitals- Hahnemann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

DISEASE CHARACTERISTICS: Stage I (T1-2 N0) nonsmall cell lung cancer curatively resected and in regular follow-up for at least 6 weeks Material available for histologic review At least 1 mediastinal node station sampled or at least 2 years since surgery Any of the following histologies eligible: Squamous cell carcinoma Large cell carcinoma Adenocarcinoma (including bronchoalveolar) No small cell anaplastic component No recurrent disease or second primary No synchronous lung cancer of a different histology Concurrent registration on intergroup protocol I91-0001 allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Cardiovascular: No history of severe hypertension, i.e.: Systolic 200 mm Hg or more Diastolic 120 mm Hg or more No MI within 6 weeks Pulmonary: Available for annual sputum induction and clinical evaluation Clinically able to undergo pulmonary function tests (PFTs) and bronchoscopy Refusal of PFTs or bronchoscopy will not effect eligibility PFTs waived if FEV1/FVC < 65% on prior testing No acute respiratory infection Other: No prior uncontrolled malignancy except nonmelanomatous skin cancer Exceptions for malignancy controlled more than 5 years discretionary

PRIOR CONCURRENT THERAPY: Complete surgical resection required as primary therapy At least 6 weeks since resection, any adjuvant chemotherapy or radiotherapy, or thoracoabdominal surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening

Collaborators and Investigators

• Sponsor: Eastern Cooperative Oncology Group
• Collaborators: National Cancer Institute (NCI); SWOG Cancer Research Network
• Investigators: Study Chair: John C. Ruckdeschel, MD, H. Lee Moffitt Cancer Center and Research Institute; Study Chair: Paul A. Bunn, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 1995
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: July 16, 2004
• First Posted (Estimated): July 19, 2004

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: stage I non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CDR0000064256; E-5593; SWOG-9437; JHOC-9152; NCI-P95-0067