Clinical trial NCT06534489: Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
Official title: Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Surgery
Keywords: lung cancer
Neo-adjuvant treatment
pneumonectomy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Huadong Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2024-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Tumor R0 resection rate (lobectomy)
timeFrame: Two weeks after surgery according to Frozen pathologic test and Paraffin pathologic test
Secondary outcomes:
measure: Lymph node dissection
timeFrame: Two weeks after surgery according to Paraffin pathologic test
measure: Duration of surgery
timeFrame: 1 month after surgery
measure: Intraoperative bleeding
timeFrame: 1 month after surgery
measure: Incidence of intraoperative accidents
timeFrame: 1 month after surgery
measure: Postoperative short-term efficacy indicators
timeFrame: 1 month after surgery
measure: Perioperative complication rate
timeFrame: 1 month after surgery
measure: 3-year disease-free survival rate
timeFrame: When all enrolled patients complete 3-year follow-up
measure: 3-year overall survival rate
timeFrame: When all enrolled patients complete 3-year follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
Study officials:
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