A Registry for People With Lung Cancer

Lung Cancer Clinical Trial

Official title:

Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424327
• Other study ID #: 24-127
• Status: Recruiting
• Start date: May 15, 2024
• Est. completion date: May 15, 2029

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: David Jones, MD
• Phone: 212-639-6428
• Email: jonesd2[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 15, 2029
• Est. primary completion date: May 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Clinical stage I tumor (AJCC 8th edition) suitable for segmentectomy, according to the treating thoracic surgeon

• Pathology of NSCLC

o Tissue diagnosis of NSCLC is not required before enrollment. A pathologic diagnosis of NSCLC may be confirmed preoperatively with biopsy, intraoperatively with frozen section, or postoperatively on final pathology.

• Patients must undergo segmentectomy for a peripheral lesion =2 cm to be included in the primary analysis. Individual ligation of the segmental artery(s) and segmental bronchus is the minimum definition for a segmentectomy. Division of the segmental vein and intraoperative frozen section to assess surgical margins and N1 lymph nodes are strongly encouraged, but the absence of either is not a criterion for exclusion.

Other considerations:

• Patients with ground-glass opacities will have their tumor size recorded on the basis of the size of the solid component.

• Any non-lung cancer treated in the past with no obvious recurrence or ongoing treatment is not a criterion for exclusion.

• The registry study will be monitored by Thoracic Surgery team at MSK.

• This study will be in collaboration with the Thoracic Surgical Oncology Group (TSOG) of the American Association for Thoracic Surgery.

Exclusion Criteria:

• Actively receiving lung cancer treatment or a history of lung cancer in the previous 5 years

• History of chemotherapy or radiation therapy for a previous lung cancer

• Synchronous secondary cancer in the lung or elsewhere in the body at the time of surgery

• Carcinoid tumors

• History of other malignancies within the past 3 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix

• Actively receiving treatment for other malignancies

• Cases of lobectomy in conjunction with segmentectomy from another lobe and =2 segmentectomies from different lobes either en bloc or separate will be excluded from the primary analysis.

• Multi-segmental resection from the same lobe is not a criterion for exclusion.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Cancer Stage I
• Lung Neoplasms

Intervention

Other:
• Patient-Reported Outcomes Measurement Information System
Participants-reported outcomes will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a web-based platform developed by the National Institutes of Health. Scoring is standardized on a scale from 0 to 100, with a population mean of 50 and standard deviation of 10 units. High scores mean more of the concept being measured. This study will use PROMIS surveys assessing three domains: physical function (PROMIS bank version 2.0), pain interference (PROMIS bank version 1.1), and dyspnea severity (PROMIS bank version 1.0)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.	DFS is measured from the date of surgery to the date of recurrence or death	3 years
Primary	Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.	DFS is measured from the date of surgery to the date of recurrence or death	5 years

External Links

•   Memorial Sloan Kettering Cancer Center