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

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00002667
• Collaborator: National Cancer Institute (NCI) (NIH), Southwest Oncology Group (Other)
• Enrollment: 1,100
• Locations: 5
• Actual Duration (Months): 111
• Patients Per Site: 220
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: cytology specimen collection procedure; Other: immunoenzyme technique; Procedure: study of high risk factors	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1100 participants
• Primary Purpose: Screening
• Official Title: EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING
• Actual Study Start Date: Jul 1, 1995
• Actual Primary Completion Date: Oct 1, 2004
• Actual Study Completion Date: Oct 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
2	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	10309-1016
3	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
4	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
5	Allegheny University Hospitals- Hahnemann	Philadelphia	Pennsylvania	United States	19102-1192

Sponsors and Collaborators

• Eastern Cooperative Oncology Group
• National Cancer Institute (NCI)
• Southwest Oncology Group

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00002667
• Other Study ID Numbers: CDR0000064256; E-5593; SWOG-9437; JHOC-9152; NCI-P95-0067
• First Posted: Jul 19, 2004
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Eastern Cooperative Oncology Group: stage I non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Jun 9, 2022