Phase II prospective randomized study of adjuvant chemoradiation in resected Stage I + II non small cell lung cancer with a companion tumor marker evaluation

Originating Group

NCIC CTGBR.10

P.I.: Dr. T. Winton

Participating Groups

Objectives

1. To determine whether adjuvant chemotherapy with cisplatinum and vinorelbine following standard treatmentwith surgery in stage I/II NSCLC improves locoregional control, or overall survival or decreases distant metastatic disease compared to observation.
2. To determine whether or not RAS mutations have prognostic significance.

Eligibility

1. Histological proof of completely resected T2N0 or T1-2N1 non-small cell lung cancer
2. A preoperative chest CT scan must be completed and intraoperative mediastinal lymph node resection or sampling should be attempted. Any mediastinal lymph node > 1.5 cm. must have been biopsied and histologically negative for the patient to be eligible for the trial.
3. Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy. Patients who have had segmentectomies or wedge resections are not eligible for this study.
4. ECOG Performance Status 0-1
5. Ineligibility Criteria: Patients who have have a diagnosis of breast cancer, melanoma or hypernephroma are ineligible. Patients with treated non-melanomaous skin cancer or carcinoma in situ of the cervix are eligible as are patients with cancers of any other type, if they remain free of recurrence and metastases five years or more following the end of treatment. Patients with bronchioalveolar carcinoma of lobar or multi-lobar involvement are ineligible whereas if it presented as a discrete solitary mass or nodule the patient is eligible. A patient with a) a combination of small cell and non-small cell carcinoma, or b) more than one discrete area of apparent primary cancer, or c) T3 tumor, or d) disease at nodal station #10 (considered N2 disease) is ineligible.

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