Clinical trial NCT04945928: Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC
Official title: Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Neoplasm
Advanced Cancer
Locally Advanced Cancer
Keywords: Conversion Therapy
Lung Cancer
Locally Advanced and Advanced NSCLC
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: perioperative morbidity
timeFrame: postoperative in-hospital stay up to 30 days
Secondary outcomes:
measure: lymph nodes counts
timeFrame: At operation day
measure: R0 rate
timeFrame: postoperative in-hospital stay up to 30 days
measure: operation time
timeFrame: At operation day
measure: blood loss
timeFrame: At operation day
measure: operative complications
timeFrame: At operation day
measure: postoperative hospital stay
timeFrame: postoperative in-hospital stay up to 30 days
measure: 30-day mortality
timeFrame: postoperative in-hospital stay up to 30 days
measure: 1-year overall survival (OS)
timeFrame: 1 year after surgery
measure: 3-year overall survival (OS)
timeFrame: 3 year after surgery
measure: 1-year disease-free survival (DFS)
timeFrame: 1 year after surgery
measure: 3-year disease-free survival (DFS)
timeFrame: 3 year after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: He-Cheng Li, doctor
role: PRINCIPAL_INVESTIGATOR
References: