An observational study in Non-small Cell Lung Cancer and Surgery, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Ruijin Hospital · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 50 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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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.
Exclusion Criteria:
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 neo-adjuvant immuno-chemotherapy. After treatment, patients should be re-evaluated and amenable to surgical treatment after multidisciplinary discussion (thoracic surgery, respiratory medicine, radiology), and open or minimally invasive radical lung cancer surgery and systematic lymph node dissection were performed, including pneumonectomy, lobectomy, double lobectomy, extended lobectomy or sleeve lobectomy. 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.
Procedure: neoadjuvant immuno-chemotherapy and surgery
After enrolled, patients should receive neo-adjuvant immuno-chemotherapy and a re-evaluation will be performed after treatment to decide surgery strategy.
Tumor R0 resection rate (lobectomy)
the proportion of patients with complete tumor removal by lobectomy, as evaluated by the pathologic findings of postoperative lung cancer specimens
Time frame: Two weeks after surgery according to Frozen pathologic test and Paraffin pathologic test
Lymph node dissection
Record the total number of lymph node dissection, the number of stations of lymph node dissection, and the number of lymph node dissection at each station during the operation,and evaluate them according to the pathologic results.
Time frame: Two weeks after surgery according to Paraffin pathologic test
Duration of surgery
Record the duration of surgery in minute（min），evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination
Time frame: 1 month after surgery
Intraoperative bleeding
Record intraoperative bleeding in milliliter （ml）, evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination
Time frame: 1 month after surgery
Incidence of intraoperative accidents
Record the incidence of intraoperative accidents in rate（%）, including bleeding，injury to normal tissue or organ， evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination
Time frame: 1 month after surgery
Postoperative short-term efficacy indicators
record the length of postoperative hospitalization (days), survival within 30 days after surgery, and evaluate through postoperative follow-up
Time frame: 1 month after surgery
Perioperative complication rate
Evaluated by clinical manifestations, laboratory tests, and physical examination
Time frame: 1 month after surgery
3-year disease-free survival rate
defined as the proportion of patients without tumor recurrence or metastasis 3 years after surgery, evaluated by postoperative follow-up
Time frame: When all enrolled patients complete 3-year follow-up
3-year overall survival rate
defined as the proportion of patients who are still alive 3 years after surgery, and evaluated by postoperative follow-up.
Time frame: When all enrolled patients complete 3-year follow-up
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