Back to resultsSafety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC
Primary Purpose
Pulmonary Neoplasm, Advanced Cancer, Locally Advanced Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Neoplasm focused on measuring Conversion Therapy, Lung Cancer, Locally Advanced and Advanced NSCLC
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.
Sites / Locations
- Ruijin hospital, Shanghai JiaoTong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery after conversion therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
perioperative morbidity
rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Secondary Outcome Measures
lymph nodes counts
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
R0 rate
R0 resection rate
operation time
duration of operation
blood loss
blood loss in the operation
operative complications
rate of adverse events happened in the operation
postoperative hospital stay
length of postoperative hospitalization
30-day mortality
30-day mortality after surgery
1-year overall survival (OS)
OS at 1 year after surgery
3-year overall survival (OS)
OS at 3 year after surgery
1-year disease-free survival (DFS)
DFS at 1 year after surgery
3-year disease-free survival (DFS)
DFS at 3 years after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04945928
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
June 5, 2024 (Anticipated)
Study Completion Date
June 5, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Neoplasm, Advanced Cancer, Locally Advanced Cancer
Keywords
Conversion Therapy, Lung Cancer, Locally Advanced and Advanced NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery after conversion therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
perioperative morbidity
Description
rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Time Frame
postoperative in-hospital stay up to 30 days
Secondary Outcome Measure Information:
Title
lymph nodes counts
Description
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
Time Frame
At operation day
Title
R0 rate
Description
R0 resection rate
Time Frame
postoperative in-hospital stay up to 30 days
Title
operation time
Description
duration of operation
Time Frame
At operation day
Title
blood loss
Description
blood loss in the operation
Time Frame
At operation day
Title
operative complications
Description
rate of adverse events happened in the operation
Time Frame
At operation day
Title
postoperative hospital stay
Description
length of postoperative hospitalization
Time Frame
postoperative in-hospital stay up to 30 days
Title
30-day mortality
Description
30-day mortality after surgery
Time Frame
postoperative in-hospital stay up to 30 days
Title
1-year overall survival (OS)
Description
OS at 1 year after surgery
Time Frame
1 year after surgery
Title
3-year overall survival (OS)
Description
OS at 3 year after surgery
Time Frame
3 year after surgery
Title
1-year disease-free survival (DFS)
Description
DFS at 1 year after surgery
Time Frame
1 year after surgery
Title
3-year disease-free survival (DFS)
Description
DFS at 3 years after surgery
Time Frame
3 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Qiang Li, doctor
Phone
00862164370045
Ext
666112
Email
whipple@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He-Cheng Li, doctor
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Qiang Li, doctor
Phone
00862164370045
Ext
666112
Email
whipple@yeah.net
12. IPD Sharing Statement
Learn more about this trial
Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC
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