Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534489
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-22
Brief Title:
Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None