Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lu… (NCT00003901) | Clinical Trial Compass
CompletedPhase 3
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
United States1,310 participantsStarted 1999-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.