Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC

Advanced Cancer Clinical Trial

Official title:

Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04945928
• Other study ID #: RTS-013
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: June 5, 2026

Study information

• Verified date: May 2024
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lung cancer is one of the most common malignant tumors worldwide and the mortality ranks first in the world. In recent years, with the development of targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, the inoperable advanced tumor remains the main reason for the poor prognosis of lung cancer. Thus, we aim to carry out this single-arm, prospective study to evaluate the safety and feasibility of surgery after conversion therapy for locally advanced and advanced non-small cell lung cancer.

Description:

Previous studies have shown that selective surgery after conversion therapy is feasible and safe in locally advanced or stage IV patients, and indicates potential benefits for these patients. However, surgery after conversion therapy is difficult and has high risk of postoperative complications which requires strict operation indications and patient screening. At present, there are only relevant retrospective studies and no prospective evidence. Therefore, our team plans to carry out this single-arm prospective clinical trial to evaluate the safety and feasibility of surgery in patients with locally advanced and advanced non-small cell lung cancer after conversion therapy, so as to lay the foundation for further research and clinical application.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 5, 2026
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent;

• More than 18 years old with no limit of sex;

• Pathologically confirmed stage T4N0-3 or T1-3N2-3 NSCLC with residual tumor after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) evaluated operable for radical resection; pathologically confirmed stage IVA NSCLC evaluated operable after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.);

• ASA score: I-III;

• Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria:

• Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation;

• Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;

• Unable to receive radical resection;

• Need of palliative or emergency operation due to lung abscess or hemoptysis;

• Having received neoadjuvant chemoradiotherapy.

Related Conditions & MeSH terms

• Advanced Cancer
• Locally Advanced Cancer
• Lung Neoplasms
• Neoplasms
• Pulmonary Neoplasm

Intervention

Procedure:
• Surgery
Participants having been evaluated as operable after receiving first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) will receive surgery.

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative morbidity	rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula	postoperative in-hospital stay up to 30 days
Secondary	lymph nodes counts	overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station	At operation day
Secondary	R0 rate	R0 resection rate	postoperative in-hospital stay up to 30 days
Secondary	operation time	duration of operation	At operation day
Secondary	blood loss	blood loss in the operation	At operation day
Secondary	operative complications	rate of adverse events happened in the operation	At operation day
Secondary	postoperative hospital stay	length of postoperative hospitalization	postoperative in-hospital stay up to 30 days
Secondary	30-day mortality	30-day mortality after surgery	postoperative in-hospital stay up to 30 days
Secondary	1-year overall survival (OS)	OS at 1 year after surgery	1 year after surgery
Secondary	3-year overall survival (OS)	OS at 3 year after surgery	3 year after surgery
Secondary	1-year disease-free survival (DFS)	DFS at 1 year after surgery	1 year after surgery
Secondary	3-year disease-free survival (DFS)	DFS at 3 years after surgery	3 year after surgery