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| Protocol Number: |
5/6/1999 |
| Trial Phase: |
Specimen/Tissue |
| Maximum # of Subjects: |
1000 |
| IRB Number: |
WIRB IRB#1049163 |
| Study Status: |
Active |
| Enrollment Status: |
Closed |
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| To evaluate whether complete mediastinal lymph node dissection results in better overall survival when compared to mediastinal lymph node sampling in the patient undergoing resection for N0 or non-hilar N1 NSCLC. |
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Eligibility |
Inclusion Criteria: A patient will be eligible for inclusion in this study only if ALL of the following criteria apply: Pre-operative: 1. Patient must > or equal to 18 years of age. 2. Patient must have an ECOG/Zubrod performance status of < or equal to 3. 3. Patient must have tissue diagnosis of a clinically resectable T1 or T2, N0 or non-hilar N1, M0 NSCLC (squamous cell carcinoma, large cell carcinoma or adenocarcinoma including bronchoalveolar carcinoma) established prior to randomization. NOTE: A patient without a pre-operative tissue diagnosis, but with clinically suspected NSCLC that fits the above criteria is eligible provided the tissue diagnosis is confirmed intraoperatively. 4. Patient must have pre-operative imaging procedure, CT Scan of the chest and upper abdomen to include liver and adrenal glands to determine eligibility, within 60 days of the date of the pulmonary resection. 5. Patient that has not had a mediastinoscopy should no mediastinal adenopathy on the CT of the chest defined as no lymph node > 1 cm in the shortest axis. 6. Patient is a candidate for a complete resection of the carcinoma via pneumonectomy, lobectomy, bilobectomy, or anatomic segmentectomy with or without sleeve resection, as noted in the surgical plan. 7. Patient, or patient's legally acceptable representative, must provide a signed and dated Z0030-specific written informed consent prior to registration and any study-related procedures. 8. If patient is a survivor of a prior cancer, the following criteria are met: a. Patient has undergone potentially curative therapy for all prior malignancies. b. No evidence of any prior malignancies for at least 5 years with no evidence of reccurrence (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), c. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies. Intra-operative: 1. Patient with righ-sided lesions must have at least nodal stations # 2R, 4R, 7 and 10 R examined. If the nodes are found, they must be sampled and proven negative by frozen section. 2. Patient with left-sided lesions must have at least nodal stations # 5, 6, 7, 10 10L examined. If the nodes are found, they must be sampled and proven negative by frozen section. 3. Any other suspicious mediastinal or hilar nodes must be sampled and proven negative by frozen section. Levels 2, 4, and 7 need not be re-sampled if they were sampled at a mediastinoscopy done within 60 days of the thoracotomy. |
Exclusion Criteria: A patient will NOT be eligible for inclusion in this study if ANY of the following criteria apply: 1. Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling. 2. Patient has T3 or T4 tumor. 3. Patient is having only a wedge resection performed for treatment. 4. Patient has received prior chemotherapy or radiotherapy for this cancer. |
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