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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: neoadjuvant immuno-chemotherapy and surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Hecheng Li; Phone Number: 13917113402; Email: lihecheng2000@hotmail.com
• Study Contact Backup: Name: Zhengxin Yin; Phone Number: 13601615676; Email: hunterfh1@163.com

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital
    • Contact: Hecheng Li, Medical Doctor; Phone Number: 13917113402; Email: lihecheng2000@hotmail.com
    • Contact: Zhengxin Yin, Medical Doctor; Phone Number: 13601615676; Email: hunterfh1@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Enrolled patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Two weeks after surgery according to Frozen pathologic test and Paraffin pathologic test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1 month after surgery
Intraoperative bleeding	Record intraoperative bleeding in milliliter （ml）, evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination	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	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	1 month after surgery
Perioperative complication rate	Evaluated by clinical manifestations, laboratory tests, and physical examination	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	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.	When all enrolled patients complete 3-year follow-up

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Huadong Hospital

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; pneumonectomy; Neo-adjuvant treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RTS-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No