Surgical Procedures for Early-Stage Lung Cancer

Recruiting in Palo Alto (17 mi)

+385 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nasser Altorki, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for adults over 18 with early-stage IA non-small cell lung cancer. Candidates should have a small lung nodule presumed to be cancer, located in the outer part of the lung, and no advanced or metastatic disease. They must not have had other cancers (except certain skin, bladder, or cervical cancers) in the past 3 years and no prior treatments for this cancer.

Inclusion Criteria

I haven't had chemotherapy or radiation for my cancer.

I can take care of myself and am up and about more than half of the day.

I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.

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Exclusion Criteria

My lung scans show ground glass opacities or I have N1 or N2 lung cancer.

Your doctor hasn't confirmed that there is no cancer spread using a quick frozen tissue test.

My right-sided tumor's nodes 4, 7, and 10 were not confirmed negative.

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Treatment Details

Interventions

Lobectomy (Procedure)
Segmentectomy (Procedure)
Wedge Resection (Procedure)

Trial OverviewThe study is comparing two less invasive surgical methods—segmentectomy or wedge resection—with lobectomy to see which one works better for stage IA non-small cell lung cancer. Patients will be randomly assigned to undergo one of these surgeries.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment1 Intervention

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

Group II: Arm AExperimental Treatment1 Intervention

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