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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04945928
Other study ID # RTS-013
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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