|Protocol No.||140503CALGB||Principal Investigator||Burrows, Whitney
|Title||A PHASE III RANDOMIZED TRIAL OF LOBECTOMY VERSUS SUBLOBAR RESECTION FOR SMALL (< or equal to 2 CM) PERIPHERAL NON-SMALL CELL LUNG CANCER
|Description||The purpose of this study is to test a different way of doing surgery for lung cancer in patients who have small tumors with no evidence of spread. The purpose of this clinical trial is to look at whether removal of a small section of lung (called a sublobar resection) is equal to a lobectomy (a larger surgery which takes out an entire section or 'lobe' of the lung, or about one-quarter to one-half of one lung, depending on which lobe is taken out) with respect to overall survival and pulmonary (lung) function.
|Treatment||Surgical Lobectomy vs. Sublobar resection
|Key Eligibility||Two sets of eligibility criteria must be met. Patients must be eligible BEFORE surgery (pre-registration) and then also eligible intraoperatively (DURING SURGERY).
Pre-registration Eligibility Criteria (Before surgery)
Peripheral lung nodule less than or equal to 2 cm on preoperative CT scan and presumed to be lung cancer.
The tumor location must be suitable for either lobar or sublobar resection (wedge or segment).
ECOG performance status of 0-2.
Age greater than or equal to 18 years.
Intra-operative Randomization Eligibility Criteria:
During surgery, the removed tumor and lymph nodes will be examined to see if the tissues are cancer. If they are determined to be cancer, then the following conditions must be met to be randomly assigned to one of the 2 surgical procedures: Lobectomy vs. Sublobar resection.
Histologic confirmation of NSCLC (if not already obtained).
Confirmation of N 0 status by frozen section examination of nodal levels 4, 7, and 10 on the right side and 5 OR 6, 7 and 10 on the left side. Levels 4 and 7 nodes may be sampled by mediastinoscopy or at the time of thoracotomy or VATS exploration. Nodes previously sampled by mediastinoscopy either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled.
Pre-Registration Exclusion Criteria (There are no Intra-operative exclusions).
Prior malignancy within 5 years other than non-melanoma skin cancer, superficial bladder cancer, or CIS of the cervix.
Prior chemotherapy or radiation therapy for this malignancy.
Evidence of locally advanced or metastatic disease.
|Applicable Disease Sites||Lung
|Contact||Upper Chesapeake Hospital Natalie Lucas-Teter||
|Supervisor, Data Mgmt. Maha Khalil, PhD||