Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
- Conditions
- SurgeryNon-small Cell Lung Cancer
- Interventions
- Procedure: neoadjuvant immuno-chemotherapy and surgery
- Registration Number
- NCT06534489
- Lead Sponsor
- Ruijin Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Enrolled patients neoadjuvant immuno-chemotherapy and surgery 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.
- Primary Outcome Measures
Name Time Method Tumor R0 resection rate (lobectomy) Two weeks after surgery according to Frozen pathologic test and Paraffin pathologic test the proportion of patients with complete tumor removal by lobectomy, as evaluated by the pathologic findings of postoperative lung cancer specimens
- Secondary Outcome Measures
Name Time Method Perioperative complication rate 1 month after surgery Evaluated by clinical manifestations, laboratory tests, and physical examination
3-year disease-free survival rate When all enrolled patients complete 3-year follow-up defined as the proportion of patients without tumor recurrence or metastasis 3 years after surgery, evaluated by postoperative follow-up
Lymph node dissection Two weeks after surgery according to Paraffin pathologic test 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.
3-year overall survival rate When all enrolled patients complete 3-year follow-up defined as the proportion of patients who are still alive 3 years after surgery, and evaluated by postoperative follow-up.
Duration of surgery 1 month after surgery Record the duration of surgery in minute（min），evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination
Intraoperative bleeding 1 month after surgery Record intraoperative bleeding in milliliter （ml）, evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination
Incidence of intraoperative accidents 1 month after surgery 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
Postoperative short-term efficacy indicators 1 month after surgery record the length of postoperative hospitalization (days), survival within 30 days after surgery, and evaluate through postoperative follow-up
Trial Locations
- Locations (1)
Ruijin hospital
🇨🇳Shanghai, China