A PHASE III RANDOMIZED TRIAL OF LOBECTOMY VERSUS SUBLOBAR RESECTION FOR SMALL (<= 2 CM) PERIPHERAL NON-SMALL CELL LUNG CANCER

Study ID
STU 012011-104

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul

Contact
Kristy Piepenbrok
214-645-7700
kristy.piepenbrok@utsouthwestern.edu

Principal Investigator
J Michael Dimaio

Summary

After pre-registration eligibility is confirmed, informed consent will be obtained from patient. Pre-registration worksheet is then completed and date is entered into the CALGB web-based system whereby a patient identification number is generated. Patients with confirmed small peripheral (<= 2 cm) NSCLC will be randomly assigned intraoperatively to either lobectomy or a sublobar resection. Arm A will be subjects randomized to receive a lobectomy and Arm B will be subjects randomized to receive the limited resection. Randomized subjects will be followed for 5 years.

Statification to be used in the randomization includes radiographic tumor size ( and amp;lt; 1 cm, 1 - 1.5cm, and and amp;gt; 1.5 - 2.0cm), histology (SCC, Adenocarcinoma, and other), and smoking status (never, former, current). A stratified permuted block randomization scheme will be used to accomplish treatment assignment.

Patients who do not meet the randomization criteria introperatively (non-small cell lung cancer (NSCLC) was not histologically confirmed, or frozen section examination did not confirm N0 status) will not be considered in the study. The type of surgery they will receive (lobectomy or wedge resection) will be made by the surgeon. The surgeon and patient will have discussed what type of surgery they would receive prior to the surgery, if in case they did not meet randomization eligibility criteria.

Study endpoints:
Primary endpoint is DFS, which is the time from randomization to disease progression or deaths from any cause, whichever comes first.
The secondary endpoints include overall survival (OS), rate of loco-regional and systemic recurrence, and expiratory flow rate at 6 months post-operatively.

Participant Eligibility

Pre-registration Eligibility Criteria:
[1] Peripheral lung node <= 2 cm on preoperative CT scan and presumed to be lung cancer. The center of the tumor as seen on CT must be located in the outer third of the lung in the transverse, coronal or a sagittal plane.
[2] The tumor location must be suitable for either lobar or sublobar resection (wedge or segment). [3] ECOG performance status of 0-2.
[4] Nor prior malignancy within 3 years other than non-melanoma skin cancer, superficial bladder cancer, or CIS of the cervix.
[5] No prior chemotherapy or radiation therapy for this malignancy.
[6] No evidence of locally advanced metastatic disease.

Intra-operative Randomization Eligibility Criteria:
[7] Age >= 18 years.
[8] Histologic confirmation of NSCLC (if not already obtained).
[9] Confirmation of N0 status by frozen section examination. Right sided tumors require that node levels 4, 7, and 10 be sampled an diagnosed as negative on frozen section. Left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed as negative on frozen section. Levels 4 and 7 nodes may be sampled by mediastinoscopy either immediately prior to or within 6 weeks of the definitive surgical procedure (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) does not need to be re-sampled.