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

NCT06534489 | Recruiting

• 1 other identifier: RTS-021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer; Surgery

Keywords

lung cancer; Neo-adjuvant treatment; pneumonectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Lymph node dissection

  Two weeks after surgery according to Paraffin pathologic test

• Duration of surgery

  1 month after surgery

• Intraoperative bleeding

  1 month after surgery

• Incidence of intraoperative accidents

  1 month after surgery

• Postoperative short-term efficacy indicators

  1 month after surgery

Study Arms (1)

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

Interventions

neoadjuvant immuno-chemotherapy and surgery PROCEDURE

After enrolled, patients should receive neo-adjuvant immuno-chemotherapy and a re-evaluation will be performed after treatment to decide surgery strategy.

Enrolled patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ruijin hospital

Shanghai, 200025, China

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Hecheng Li

CONTACT

13917113402; lihecheng2000@hotmail.com

Zhengxin Yin

CONTACT

13601615676; hunterfh1@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: August 2, 2024
• Study Start: August 31, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 2, 2024

Record last verified: 2024-05

Locations

CN (1)