NCT00499330|CompletedPhase 3

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

CALGB 140503CALGB-140503CDR0000555324NCI-2009-00447

Study Type

interventional

Target

701

Locations

3 countries

Sites

386

Timeline

RegisteredJul 2007

StartedOct 2007

CompletionSep 2025

Brief Summary

RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

701

participants targeted

Target at P75+ for phase_3 lung-cancer

Timeline

Completed

Started Oct 2007

Longer than P75 for phase_3 lung-cancer

Geographic Reach

3 countries

386 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

18 years study duration

First Submitted

Initial submission to the registry

July 10, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed

3 months until next milestone

Study Start

First participant enrolled

October 12, 2007

Completed

18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

18 years

First QC Date

July 10, 2007

Last Update Submit

January 20, 2026

Conditions

Lung Cancer

Keywords

stage IA non-small cell lung canceradenocarcinoma of the lungsquamous cell lung cancerlarge cell lung canceradenosquamous cell lung cancerbronchoalveolar cell lung cancer

Outcome Measures

Primary Outcomes (1)

disease-free survival
Up to 7 years

Secondary Outcomes (3)

overall survival
Up to 7 years
rate of loco-regional and systemic recurrence
Up to 7 years
pulmonary function as measured by expiratory flow rate 6 months postoperatively
at 6 months

Study Arms (2)

Arm A

OTHER

Patients undergo a standard operation for lung cancer called a lobectomy.

Procedure: lobectomy

Arm B

EXPERIMENTAL

Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.

Procedure: segmentectomy or wedge resection

Interventions

lobectomyPROCEDURE

Arm A

segmentectomy or wedge resectionPROCEDURE

Arm B

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Pre-registration Eligibility Criteria: 1. Peripheral lung nodule ≤ 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 either the transverse, coronal or sagittal plane. Patients with pure ground glass opacities or pathologically confirmed N1 or N2 disease are not eligible. 2. The tumor location must be suitable for either lobar or sublobar resection (wedge or segment). 3. ECOG performance status of 0-2. 4. No 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 or metastatic disease. 7. Age ≥ 18 years Intra-operative Randomization Eligibility Criteria: 1. Histologic confirmation of NSCLC (if not already obtained) 2. Confirmation of N0 status by frozen section examination. Right sided tumors require that node levels 4, 7, and 10 be sampled and 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, endobronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or VATS exploration. Nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (386)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC