Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Surgery; Non-small Cell Lung Cancer

Treatments: Procedure: neoadjuvant immuno-chemotherapy and surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06534489

RTS-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Enrolled patients

Description:

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.

Treatment:

Procedure: neoadjuvant immuno-chemotherapy and surgery