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.

Condition
screening for lung cancer stage I non-small cell lung cancer

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

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

--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

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

Study chairs or principal investigators

John C. Ruckdeschel,  Study Chair,  Eastern Cooperative Oncology Group   
Charles A. Coltman, Jr.,  Study Chair

Study ID Numbers:  CDR0000064256; E-5593; NCI-P95-0067; JHOC-9152
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002667
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08