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A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer



- Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA
non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection
or segmentectomy).


- Compare the overall survival of patients undergoing lobectomy vs sublobar resection.

- Compare the rates of loco-regional and systemic recurrence in patients undergoing
lobectomy vs sublobar resection.

- Compare the pulmonary function of these patients, as measured by expiratory flow rates
at 6 months postoperatively.

- Explore the relationship between characteristics of the primary lung cancer, as
revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and

- Determine the false-negative rate of preoperative PET scan for identification of
involved hilar and mediastinal lymph nodes.

- Assess the utility of annual follow-up CT scan after surgical resection in these

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to tumor
size (< 1 cm vs 1-1.5 cm vs > 1.5-2.0 cm) (based on the maximum dimension determined from
the preoperative scan), histology (squamous cell carcinoma vs adenocarcinoma vs other), and
smoking status (never smoked [smoked < 100 cigarettes over lifetime] vs former smoker
[smoked > 100 cigarettes AND quit ≥ 1 year ago] vs current smoker [quit < 1 year ago or
currently smokes]). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic
surgery (VATS).

- Arm II: Patients undergo a wedge resection or anatomical segmentectomy by open
thoracotomy or VATS.

After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually for 5 years.

Inclusion Criteria


- Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and
intraoperative criteria:

- Preoperative criteria

- Peripheral lung nodule ≤ 2 cm by CT scan

- Center of the tumor must be located in the outer third of the lung in
either the transverse, coronal, or sagittal plan

- Tumor location must be suitable for either lobar or sublobar resection
(wedge resection or segmentectomy)

- No pure ground opacities or pathologically confirmed N1 or N2 disease

- Intraoperative criteria

- Histologically confirmed NSCLC

- Confirmation of N0 status by frozen section examination of nodal levels 4,
7, and 10 on the right side and 5, 6, 7, and 10 on the left side*

- Levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial
ultrasound (EBUS), and/or endoscopic ultrasound (EUS), or at the time
of thoracotomy or video-assisted thoracoscopic surgery (VATS)
exploration* NOTE: *Nodes previously sampled by mediastinoscopy (or
EBUS and/or EUS) either immediately before or within 6 weeks of the
definitive surgical procedure (thoracotomy or VATS) do not need to be

- No evidence of locally advanced or metastatic disease


- ECOG performance status 0-2

- No other malignancy within the past 3 years except for nonmelanoma skin cancer,
superficial bladder cancer, or carcinoma in situ of the cervix


- No prior chemotherapy or radiotherapy for this malignancy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:


Principal Investigator

Nasser K. Altorki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University



Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IA non-small cell lung cancer
  • adenocarcinoma of the lung
  • squamous cell lung cancer
  • large cell lung cancer
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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