Lung Cancer Clinical Trial
Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
Summary
RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.
PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
Full Description
OBJECTIVES:
Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.
Determine the relationship between these indicators and conventional histology.
Model survival considering the indicators and other patient attributes that are of prime prognostic significance.
Determine the relationships between the indicators and the site of first recurrence in these patients.
Determine the prevalence of the indicators in these patients.
Determine the relationships between the indicators and disease free survival in these patients.
Eligibility Criteria
Inclusion Criteria:
Patient must be ≥ 18 years old.
Patient must have ECOG/Zubrod status < 3.
Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.
Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.
Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.
Patient must be medically fit for surgery.
Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
Patient must be available for follow-up.
If the patient is a survivor of a prior cancer, all of the following criteria must apply:
Patient has undergone potentially curative therapy for all prior malignancies,
No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
Exclusion Criteria:
Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.
Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
Patient has received prior chemotherapy or radiotherapy for this cancer.
Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
Patient for whom the surgeon plans to perform only a wedge resection for treatment.
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There are 58 Locations for this study
Mobile Alabama, 36608, United States
Mobile Alabama, 36640, United States
Los Angeles California, 90033, United States
Pasadena California, 91105, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
Denver Colorado, 80262, United States
Fort Lauderdale Florida, 33308, United States
Saint Petersburg Florida, 33701, United States
Chicago Illinois, 60637, United States
Elk Grove Village Illinois, 60007, United States
Springfield Illinois, 62701, United States
Springfield Illinois, 62702, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40202, United States
Flint Michigan, 48432, United States
Flint Michigan, 48503, United States
Royal Oak Michigan, 48073, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68105, United States
Omaha Nebraska, 68131, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Greensburg Pennsylvania, 15601, United States
New Castle Pennsylvania, 16105, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15243, United States
Wynnewood Pennsylvania, 19096, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37212, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Murray Utah, 84107, United States
Salt Lake City Utah, 84143, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98108, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Morgantown West Virginia, 26506, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
London Ontario, N6A 4, Canada
Toronto Ontario, M5G 2, Canada
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