(CALGB 140503) A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (< 2 cm) Peripheral Non-Small Cell Lung Cancer

Title (CALGB 140503) A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (< 2 cm) Peripheral Non-Small Cell Lung Cancer

Contact EF

Principal Investigator Chukwumere Nwogu, MD

Study Number 111407

Phase3

Summary

Patients with small peripheral NSCLC will be randomly assigned to either lobectomy or a sublobar resection (wedge resection or segmentectomy). The surgeon will determine if the tumor is the correct size (<2cm) during surgery to qualify a patient for this protocol. At that time the information will be entered into the computer program to randomize the patient to a lobectomy or to sublobar resection. Patients will be followed yearly up to 5 years to determine whether disease free survival (DFS) is non-inferior following sublobar resection compared to lobectomy.

An imaging substudy is also embedded in this protocol to compare pre-operative CT or PET scan imaging characteristics with survival rate and rate of tumor recurrence outcomes.

Eligibility

PRE REGISTRATION CRITERIA

Peripheral lung nodule < or = 2cm on CT and presumed to be lung cancer
Tumor location suitable for either lobar or sublobar resection
ECOG PS: 0-2
No prior malignancy within 3 years
No prior chemotherapy or radiation therapy for this malignancy
No evidence of locally advanced or metastatic disease
Age > or = 18 years

INTRA-OPERATIVE RANDOMIZATION CRITERIA

Histologic confirmation of NSCLC
Confirmation of N0 status

For more information about the clinical study go to Clinicaltrial.Gov