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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002667
• Date of registration: 01/11/1999
• Primary sponsor: Eastern Cooperative Oncology Group
• Public title: Early Detection of Second Lung Cancer in Patients With Stage I Non-small Cell Lung Cancer
• Scientific title: EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING
• Date of first enrolment: July 1995
• Target sample size: 1100
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00002667
• Study type: Interventional
• Study design: Primary Purpose: Screening

Countries of recruitment

United States

Contacts

• Name: John C. Ruckdeschel, MD
• Affiliation: H. Lee Moffitt Cancer Center and Research Institute

• Name: Paul A. Bunn, MD
• Affiliation: University of Colorado, Denver

Key inclusion & exclusion 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Other: cytology specimen collection procedure

Other: immunoenzyme technique

Procedure: study of high risk factors

Secondary ID(s)

CDR0000064256

E-5593

JHOC-9152

NCI-P95-0067

SWOG-9437

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Southwest Oncology Group