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
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: immunohistochemistry staining method; biopsy; surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; adenocarcinoma of the lung

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must be ≥ 18 years old.

          2. Patient must have ECOG/Zubrod status < 3.

          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.

          4. Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if
             preoperative studies suggest N3 disease.

          5. Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC
             prior to registration.

          6. 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.

          7. Patient must be medically fit for surgery.

          8. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy,
             bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.

          9. 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.

         10. Patient must be available for follow-up.

         11. If the patient is a survivor of a prior cancer, all of the following criteria must
             apply:

               1. Patient has undergone potentially curative therapy for all prior malignancies,

               2. 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),

               3. Patient is deemed by their treating physician to be at low risk for recurrence
                  from prior malignancies.

        Exclusion Criteria:

          1. Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray,
             or by chest CT scan.

          2. Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.

          3. Patient has received prior chemotherapy or radiotherapy for this cancer.

          4. Patient is considered a poor surgical risk due to non-malignant systemic disease
             (cardiovascular, renal, etc.) that would preclude the treatment options.

          5. Patient for whom the surgeon plans to perform only a wedge resection for treatment.