Surgical Procedures for Early-Stage Lung Cancer

Recruiting at 385 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Prior malignancy, Chemotherapy, Radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

701 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Surgical Procedures for Early-Stage Lung Cancer?

Research suggests that sublobar resection, which includes segmentectomy and wedge resection, can be a good alternative to lobectomy for certain early-stage lung cancer patients, especially those with small, peripheral tumors. While lobectomy is still considered the standard treatment, sublobar resection may offer similar survival outcomes with less impact on lung function for select patients. ^{1 2 3 4 5}

Is surgery for early-stage lung cancer safe?

Sublobar resection (a smaller surgery) and lobectomy (removal of a lung lobe) are generally safe for early-stage lung cancer, with sublobar resection possibly reducing the risk of memory and thinking problems after surgery compared to lobectomy. ^{4 6 7 8 9}

How does the treatment of lobectomy, segmentectomy, and wedge resection differ from other treatments for early-stage lung cancer?

Lobectomy is the standard treatment for early-stage lung cancer, but sublobar resections like segmentectomy and wedge resection are alternatives for patients with smaller tumors or those who cannot tolerate a full lobectomy. These sublobar procedures are less invasive and may be suitable for high-risk patients, though they might have a higher chance of cancer returning compared to lobectomy. ^{1 4 10 11 12}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a lobectomy or a sublobar resection (segmentectomy or wedge resection) to treat stage IA non-small cell lung cancer

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 6 months for 2 years and then annually for 5 years

7 years

Treatment Details

Interventions

• Lobectomy
• Segmentectomy
• Wedge Resection

Trial Overview The 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

Group I: Arm B Experimental Treatment 1 Intervention

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

Group II: Arm A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Sublobar resection, including both non-anatomic wedge resection and anatomic segmentectomy, is a promising alternative to lobectomy for selected lung cancer patients, potentially causing less pulmonary compromise.

Current evidence suggests that sublobar resection may achieve survival outcomes similar to lobectomy for patients with stage IA lung cancer, tumors up to 2-3 cm, peripheral location, and predominantly ground-glass appearance on CT, but more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-small cell lung cancer: when to offer sublobar resection. Sihoe, AD., Van Schil, P.[2022]

Lobectomy is associated with better 5-year survival rates (57.5%) compared to sublobar resection (36%) in patients with second primary lung cancer, suggesting it should be the preferred treatment option.

Sublobar resection remains a valid alternative for high-risk patients with limited lung function, while completion pneumonectomy is linked to significantly poorer long-term survival (20%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is lobectomy really more effective than sublobar resection in the surgical treatment of second primary lung cancer? Zuin, A., Andriolo, LG., Marulli, G., et al.[2022]

In a study analyzing data from the Surveillance, Epidemiology, and End Results database involving patients with early non-small cell lung cancer (NSCLC), segmentectomy showed similar overall survival (OS) and lung cancer-specific survival (LCSS) rates compared to lobectomy after adjusting for biases through propensity score matching.

Before matching, lobectomy was associated with better survival outcomes, but after matching, the differences in survival rates between segmentectomy and lobectomy were not statistically significant, suggesting that segmentectomy can be a viable surgical option for patients with early-stage NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lobectomy versus segmentectomy in patients with stage T (> 2 cm and ≤ 3 cm) N0M0 non-small cell lung cancer: a propensity score matching study. Wang, L., Ge, L., You, S., et al.[2022]

Anatomical segmentectomy, compared to lobectomy, significantly reduces postoperative complications such as atelectasis, pneumonia, and prolonged air leaks, indicating it may be a safer surgical option for early-stage lung cancer.

Despite the reduced morbidity associated with segmentectomy, there was no significant difference in postoperative mortality rates at 30, 60, or 90 days, suggesting that while segmentectomy may lead to fewer complications, it does not impact overall survival in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest of anatomical segmentectomy over lobectomy for lung cancer: a nationwide study. Berg, E., Madelaine, L., Baste, JM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sublobar resection for early-stage lung cancer. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Non-small cell lung cancer: when to offer sublobar resection. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of extent of resection on outcomes in patients with limited stage small cell lung cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Is lobectomy really more effective than sublobar resection in the surgical treatment of second primary lung cancer? [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Real-world survival outcomes of wedge resection versus lobectomy for cT1a/b cN0 cM0 non-small cell lung cancer: a single center retrospective analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Lobectomy versus segmentectomy in patients with stage T (> 2 cm and ≤ 3 cm) N0M0 non-small cell lung cancer: a propensity score matching study. [2022]

7. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of perioperative and survival outcomes between sublobar resection and lobectomy of patients who underwent a second pulmonary resection. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Sublobar resection reduces the risk of postoperative cognitive dysfunction compared with lobectomy. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes of sublobar resection vs lobectomy for invasive clinical stage T1N0 non-small-cell lung cancer: A propensity-match analysis. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Segmentectomy versus wedge resection for non-small cell lung cancer in high-risk operable patients. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Interest of anatomical segmentectomy over lobectomy for lung cancer: a nationwide study. [2022]

12. China pubmed.ncbi.nlm.nih.gov

Open, thoracoscopic and robotic segmentectomy for lung cancer. [2022]