Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Surgery after conversion therapy Participants with locally advanced or advanced NSCLC who received first-line treatment have been evaluated as resectable after multidisciplinary discussion involving the department of thoracic surgery, respiratory medicine, radiology and oncology. |
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.
|
Outcome Measures
Primary Outcome Measures
- perioperative morbidity [postoperative in-hospital stay up to 30 days]
rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Secondary Outcome Measures
- lymph nodes counts [At operation day]
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
- R0 rate [postoperative in-hospital stay up to 30 days]
R0 resection rate
- operation time [At operation day]
duration of operation
- blood loss [At operation day]
blood loss in the operation
- operative complications [At operation day]
rate of adverse events happened in the operation
- postoperative hospital stay [postoperative in-hospital stay up to 30 days]
length of postoperative hospitalization
- 30-day mortality [postoperative in-hospital stay up to 30 days]
30-day mortality after surgery
- 1-year overall survival (OS) [1 year after surgery]
OS at 1 year after surgery
- 3-year overall survival (OS) [3 year after surgery]
OS at 3 year after surgery
- 1-year disease-free survival (DFS) [1 year after surgery]
DFS at 1 year after surgery
- 3-year disease-free survival (DFS) [3 year after surgery]
DFS at 3 years after surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent;
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More than 18 years old with no limit of sex;
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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.);
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ASA score: I-III;
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Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.
Exclusion Criteria:
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Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation;
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Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
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Unable to receive radical resection;
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Need of palliative or emergency operation due to lung abscess or hemoptysis;
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Having received neoadjuvant chemoradiotherapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai | China | 021 |
Sponsors and Collaborators
- Ruijin Hospital
Investigators
- Principal Investigator: He-Cheng Li, doctor, Ruijin Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RTS-013