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

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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