Randomized prospective trial of mediastinal lymph node sampling versus complete lymphadenectomy during the conduct of pulmonary resection in patients with N0 and N1 (less than hilar) no-small cell carcinoma

Originating Group

ACS-OG Z0030

P.I.: Dr. Mark Allen Dr. Gail Darling Dr. Robert Ginsberg

Endpoints

Primary: 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 non-small cell lung cancer. Secondary:

1. To compare mediastinal lymph node sampling to complete mediastinal lymph node dissection with reference to identification of occult mediastinal lymph node metastasis.
2. To assess whether complete mediastinallymph node dissection adversely effects the patient in reference to operative time, postoperative complications, duration of chest drainage and length of hospitalization, as compared to mediastinal lymph node sampling.
3. To evaluate whether complete mediastinal lymph node dissection improves local recurrence-free survival and local-regional recurrence-free survival as compared to mediastinallymph node sampling.

Pre-operative Eligibility

The following eligibility criteria must be assessed and passed prior to the throacotomy:

1. Patient must have biopsy proven or suspected, clinically resectable, T1 or T2, N0 or non-hilar N1, M0 non-small cell carcinoma of the lung.
2. Patients who have not had a tissue diagnosis established preoperatively must have this established intraoperatively prior to registration/randomization by TruCut biopsy or wedge resection and frozen section.
3. If pre-operative mediastinsoscopy has been performed, the patient must not have been found to have N2 disease at mediastinoscopy.
4. If pre-operative mediastinscopy has not been performed, all lymph nodes in the hilum and mediastinum must measure < 1cm. in the short axis diameter on pre-operative CT scan.
5. 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. A patient in whom the surgeon plans to perform only a wedge resection for treatment is not eligible.
6. Patient must be 18 yrs of age or older.
7. Patient's performance status must be less than 3 on the ECOG/Zubrod scale.
8. Patient must not have received prior chemotherapy or radiotherapy for this cancer.
9. A cancer survivor is eligible provided that the following criteria are met: a) the patient has undergone potentially curative therapy for all prior malignancies, (b) there has been no evidence of any prior malignancies for at least 5 years, and (c) the patient has been deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Intra-operative Eligibility Requirements

At thoracotomy, the tumor will be assessed by the sugeon as to suitaility for complete resection. Lymph node sampling will be performed. Nodes are identified using PET, CT scan and intraioeratively. For right-sided tumors, levels R2,4,7, and 10 are to be sampled, and for left-sided tumors, levels 5,6,7,and 10 and any other suspicious mediastinal lymph nodes will be sampled. Levels 2 and 4 need not be resampled at thoracotomy if a previous mediastinoscopy had indicated "negative" lymph nodes. All aove lymph nodes must be submitted for froen section and pathologic assessment must be made prior to registration/randomization. Thus, the following additional eligibility criterion must be met: All sampled nodes must be negative by frozen section assessment.

Schema

Comments

activated 9/1999

target accrual 1000 patients

accrual __ /1000 as of __/99