Segmentectomy for Lung Cancer

(SAINT Trial)

Overseen By Ankit Bharat, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Investigational agents

Disqualifiers: Prior lung surgery, Uncontrolled hypertension, Active infection, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). T1c is tumor staging 1 and c stands for tumor is considered larger than 2cm but no larger than 3cm across; N0 is No regional lymph node metastasis; M0 is No distant metastasis.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on investigational agents or have uncontrolled illnesses that require systemic treatment, you may not be eligible to participate.

What data supports the effectiveness of the treatment Segmentectomy for Lung Cancer?

Research shows that segmentectomy, a type of sublobar resection, can be a safe and effective alternative to lobectomy for small lung cancers (less than 2 cm) and may offer longer overall survival for patients with small-sized non-small cell lung cancer compared to lobectomy. ^{1 2 3 4 5}

Is segmentectomy generally safe for humans?

Segmentectomy, including video-assisted thoracoscopic surgery (VATS) segmentectomy, is considered a safe procedure for treating small lung cancers, especially in patients with other health issues. Studies show it can be as safe as traditional open surgery, with low rates of complications during and after the procedure. ^{1 2 6 7 8}

How does segmentectomy differ from other treatments for lung cancer?

Segmentectomy is a surgical treatment for early-stage lung cancer that involves removing a specific segment of the lung, making it less invasive than a lobectomy, which removes an entire lobe. It is particularly considered for small tumors (up to 2-3 cm) in patients who may not tolerate more extensive surgery, and it aims to preserve more lung function while potentially offering similar survival outcomes for select patients. ^{1 4 5 9 10}

Research Team

Ankit Bharat, M.D.

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for patients with a specific stage of non-small cell lung cancer (NSCLC) who have undergone treatment to shrink the tumor. They must now have a small tumor (2-3cm), no spread to lymph nodes or other parts of the body, and be candidates for a type of surgery called segmentectomy.

Inclusion Criteria

My lung cancer is confirmed and at an early stage after initial treatment.

I have a history or symptoms of heart disease but can undergo surgery with anesthesia.

I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

Patients receiving any other investigational agents

My cancer has spread to distant parts of my body, including possibly the brain.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive neoadjuvant therapy to downstage lung cancer before surgery

6-8 weeks

Surgical Resection

Participants undergo segmentectomy to achieve R0 resection after induction therapy

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgical resection

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Segmentectomy

Trial Overview The SAINT trial is testing the success rate of performing segmentectomy, which is a precise surgical procedure to remove part of a lung lobe, in patients whose tumors were reduced by prior therapy to meet certain size criteria.

Participant Groups

Group I: Segmentectomy after Induction Therapy Experimental Treatment 1 Intervention

Surgical intervention (segmentectomy) post induction therapy for Non-Small Cell Lung Cancer

Segmentectomy is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Segmentectomy for:

• Non-small cell lung cancer (NSCLC)

Approved in European Union as Segmentectomy for:

• Early-stage non-small cell lung cancer (NSCLC)

Approved in Japan as Segmentectomy for:

• Small-sized peripheral non-small cell lung cancer (NSCLC)

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Collaborator

Trials

1

Recruited

30+

Findings from Research

Video-assisted thoracoscopic surgery (VATS) segmentectomy is a safe and effective alternative to open segmentectomy for patients with small lung cancers (<2 cm), showing significantly fewer complications and shorter hospital stays.

In a study of 41 patients, those who underwent VATS had no major complications, while 19% of patients in the open group experienced major complications, highlighting the potential benefits of the VATS approach for patients with limited cardiopulmonary reserve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-assisted thoracoscopic surgery segmentectomy: a safe and effective procedure. Leshnower, BG., Miller, DL., Fernandez, FG., 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]

In a study of 26,517 patients with small-sized non-small cell lung cancer (NSCLC), those who underwent at least 10 lymph node dissections (LNDs) during sublobar resection had significantly better overall survival compared to those with 9 or fewer LNDs, indicating the importance of thorough lymphadenectomy.

The findings suggest that performing 10 or more LNDs is a critical factor for improving prognosis in patients with small-sized NSCLC, regardless of whether they had segmentectomy or wedge resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymph node dissections and survival in sublobar resection of non-small cell lung cancer ≤ 20 mm. Takamori, S., Komiya, T., Shimokawa, M., et al.[2023]

In a study of 419 patients aged 80 and older with early-stage non-small cell lung cancer (NSCLC) tumors between 2 to 4 cm, sublobar resection showed a slightly lower but not statistically significant 5-year overall survival rate compared to lobectomy (54.7% vs 66.8%).

For patients who could tolerate lobectomy, the 5-year overall survival rates were comparable between those who underwent sublobar resection and those who had lobectomy (67.5% vs 71.5%), suggesting that sublobar resection may be a viable option for selected elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublobar Resection for Non-Small Cell Lung Cancer in Octogenarians: A Prospective, Multicenter Study. Mimae, T., Saji, H., Nakamura, H., et al.[2023]

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]

In a study of 232 patients undergoing thoracoscopic anatomical segmentectomies for lung cancer, the procedure demonstrated a low conversion rate to open surgery (3.4%) and a minimal rate of unplanned additional resections (3%), indicating it can be performed safely.

The paper emphasizes the importance of adhering to oncological criteria during thoracoscopic segmentectomies to ensure effective treatment of non-small cell lung carcinoma (NSCLC) and discusses technical refinements to enhance safety and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracoscopic anatomic segmentectomies for lung cancer: technical aspects. Gossot, D., Lutz, J., Grigoroiu, M., et al.[2022]

In a multicenter phase 3 trial involving 396 patients with non-small-cell lung cancer (NSCLC) tumors up to 3 cm, segmentectomy achieved an impressive 5-year relapse-free survival rate of 98%, surpassing the pre-set threshold of 87%.

The procedure demonstrated a favorable safety profile, with only 2% of patients experiencing grade 3 or 4 complications and no treatment-related deaths, suggesting that segmentectomy is a viable surgical option for early-stage NSCLC, particularly for tumors with ground-glass opacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Segmentectomy for ground-glass-dominant lung cancer with a tumour diameter of 3 cm or less including ground-glass opacity (JCOG1211): a multicentre, single-arm, confirmatory, phase 3 trial. Aokage, K., Suzuki, K., Saji, H., et al.[2023]

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]

Sublobar resection, specifically segmentectomy, is being recognized as a viable alternative to lobectomy for treating small-sized non-small cell lung cancer (NSCLC), particularly for T1 tumors ≤ 3 cm, with studies suggesting equivalent outcomes.

Segmentectomy is preferred over wedge resection because it allows for better oncological management through nodal dissection, and surgeons should be skilled in this technique as early detection of small lung cancers increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radical segmentectomy]. Okada, M.[2014]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Video-assisted thoracoscopic surgery segmentectomy: a safe and effective procedure. [2022]

2. China pubmed.ncbi.nlm.nih.gov

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

3. Japan pubmed.ncbi.nlm.nih.gov

Lymph node dissections and survival in sublobar resection of non-small cell lung cancer ≤ 20 mm. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Sublobar Resection for Non-Small Cell Lung Cancer in Octogenarians: A Prospective, Multicenter Study. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

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

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. China pubmed.ncbi.nlm.nih.gov

Thoracoscopic anatomic segmentectomies for lung cancer: technical aspects. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Segmentectomy for ground-glass-dominant lung cancer with a tumour diameter of 3 cm or less including ground-glass opacity (JCOG1211): a multicentre, single-arm, confirmatory, phase 3 trial. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

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

10. Japan pubmed.ncbi.nlm.nih.gov

[Radical segmentectomy]. [2014]