Trial Title:
Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
NCT ID:
NCT06534489
Condition:
Non-small Cell Lung Cancer
Surgery
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
lung cancer
Neo-adjuvant treatment
pneumonectomy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
neoadjuvant immuno-chemotherapy and surgery
Description:
After enrolled, patients should receive neo-adjuvant immuno-chemotherapy and a
re-evaluation will be performed after treatment to decide surgery strategy.
Arm group label:
Enrolled patients
Summary:
Lung cancer is one of the most common malignant tumors worldwide and has the highest
mortality rate among malignant tumors. In recent years, with the gradual development of
therapeutic modalities such as targeted therapy and immunotherapy, the overall survival
of lung cancer patients has improved significantly. However, late tumor staging at the
time of diagnosis often leaves patients with only pneumonectomy, which affects the
prognosis with a higher rate of postoperative complications than lobectomy, poorer
quality of life and the possible loss of the opportunity to continue adjuvant therapy.
Our group proposes to conduct this single-arm prospective clinical study to investigate
the feasibility, safety and prognosis of the conversion from pneumonectomy to lobectomy
after neoadjuvant or induction therapy in patients with operable non-small cell lung
cancer.
Detailed description:
We propose to conduct a multicenter, single-arm prospective clinical study to investigate
the feasibility, safety and prognosis of the conversion from pneumonectomy to lobectomy
after neoadjuvant or induction therapy in patients with operable non-small cell lung
cancer. The anticipated sample size is 50 patients. Study will last 5 years.
After the patients were enrolled in the group, further relevant examinations (chest
enhancement CT, PET-CT (optional), cranial MR, bronchoscopy, cardiac ultrasound,
pulmonary function, electrocardiogram, blood tests) were completed, contraindications to
surgery were ruled out, and the patients were evaluated to receive neoadjuvant or
induction chemo-immunotherapy after multidisciplinary discussion (thoracic surgery,
respiratory medicine, radiology). After the patients completed these treatments, systemic
preoperative examinations should be underwent (chest enhancement CT, PET-CT (optional),
cranial MR, bronchoscopy, cardiac ultrasound, pulmonary function, electrocardiogram,
blood tests) and open or minimally invasive radical lung cancer surgery and systematic
lymph node dissection were performed. The perioperative complications, lymph node
dissection, R0 clearance rate, 3-year event-free survival rate, overall and disease-free
survival rate, quality of life, and pulmonary function were recorded and evaluated.
The surgical strategies include pneumonectomy, double lobectomy, sleeve lobectomy and
lobectomy.
The patients will be followed up in one and three months after surgery. Then every three
months in first year, every six months after one year of operation, with blood routine,
biochemistry, tumor indexes, and chest CT examination at each visit. Within one year
after surgery, head MR was performed every six months and PET-CT was performed at one
year, and after one year after surgery, head MR was performed every six months and PET-CT
was performed every year.
The researchers will contact the study participants or their families via the Internet or
telephone to inform them of the treatment schedule and remind them of follow-up visits.
Criteria for eligibility:
Study pop:
Source of study subjects: outpatients Recruitment location: Thoracic Surgery and
Respiratory Medicine Clinic of participant centers.
Recruitment method:Through WeChat public number, departmental website and other online
channels to publish recruitment information.
The researchers conducted a study on the lungs of patients attending outpatient clinics.
After preliminary evaluation of lung cancer patients in the outpatient clinic of Ruijin
Hospital and identification of those who are potentially eligible for enrollment, as well
as improvement of chest CT, PET-CT（optional）, cardiac ultrasound, lung function and other
auxiliary examinations, and after it is clear that they are eligible for enrollment,
subjects will be informed of the study and will sign an informed consent form.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- The patients voluntarily participate in the study, have good compliance, can
cooperate with the requirements of the experiment to complete the observation and
follow-up, and sign the informed consent form.
- Aged over 18 years old, under 75 years old; male and female are not limited;
- Pathologically confirmed non-small cell lung cancer with clinical stage T2-4N0-2,
resectable non-small cell lung cancer, potentially needing pneumonectomy and
receiving neoadjuvant or induction therapy.
- ASA score: Grade I-III;
- The cardiopulmonary function evaluation can meet the requirements for radical lung
cancer surgery, and the liver and kidney functions are normal.
Exclusion Criteria:
- Those with serious cardiac, pulmonary, hepatic, and renal dysfunctions, unable to
tolerate the surgery;
- Those with uncontrollable neurological or psychiatric diseases or mental disorders,
poor compliance, and being unable to cooperate and describe the treatment response.
- Those who are going to undergo emergency surgery or palliative surgery due to lung
abscess or hemoptysis.
- Those who have been treated, or are undergoing neoadjuvant or induction radiotherapy
or targeted therapy.
- Those who have a combined history of other malignant tumors
- Those who have a history of thoracic surgery
- Those who are pregnant or breastfeeding women
- Patients of childbearing age who refuse to use contraception.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Hecheng Li, Medical Doctor
Phone:
13917113402
Email:
lihecheng2000@hotmail.com
Contact backup:
Last name:
Zhengxin Yin, Medical Doctor
Phone:
13601615676
Email:
hunterfh1@163.com
Start date:
August 31, 2023
Completion date:
August 31, 2029
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Huadong Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06534489
