Evaluating surgical options for lung cancer patients after initial treatment
Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
This study is testing if switching from a major lung surgery to a smaller one is safe and helpful for lung cancer patients who have already received treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06534489 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility, safety, and prognosis of converting from pneumonectomy to lobectomy in patients with operable non-small cell lung cancer (NSCLC) who have undergone neoadjuvant or induction therapy. The study will involve a multicenter approach with an anticipated sample size of 50 patients over a duration of five years. Participants will undergo a series of preoperative evaluations and treatments, including neoadjuvant immuno-chemotherapy, followed by surgical intervention. Outcomes such as perioperative complications, survival rates, and quality of life will be meticulously recorded and analyzed.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed resectable NSCLC who require pneumonectomy and are eligible for neoadjuvant or induction therapy.
Not a fit: Patients with serious cardiac, pulmonary, hepatic, or renal dysfunctions who cannot tolerate surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for lung cancer patients by potentially reducing the need for more invasive pneumonectomy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving surgical outcomes for lung cancer patients, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Ruijin hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Hecheng Li
- Email: lihecheng2000@hotmail.com
- Phone: 13917113402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.