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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Tumor R0 resection rate (lobectomy) [Time frame: Two weeks after surgery according to Frozen pathologic test and Paraffin pathologic test]

Secondary outcome measures (8)

• Lymph node dissection [Time frame: Two weeks after surgery according to Paraffin pathologic test]
• Duration of surgery [Time frame: 1 month after surgery]
• Intraoperative bleeding [Time frame: 1 month after surgery]
• Incidence of intraoperative accidents [Time frame: 1 month after surgery]
• Postoperative short-term efficacy indicators [Time frame: 1 month after surgery]
• Perioperative complication rate [Time frame: 1 month after surgery]
• 3-year disease-free survival rate [Time frame: When all enrolled patients complete 3-year follow-up]
• 3-year overall survival rate [Time frame: When all enrolled patients complete 3-year follow-up]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Ruijin hospital — Shanghai

Publications

• Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Akinyemiju TF, Al Lami FH, Alam T, Alizadeh-Navaei R, Allen C, Alsharif U, Alvis-Guzman N, Amini E, Anderson BO, Aremu O, Artaman A, Asgedom SW, Assadi R, Atey TM, Avila-Burgos L, Awasthi A, Ba Saleem HO, Barac A, Bennett JR, Bensenor IM, Bhakta N, Brenner H, Cahuana-Hurtado L, Castaneda-Orjuela CA, Catala-Lopez F, Choi JJ, Christopher PMID 29860482
• Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open- PMID 35461558
• Altorki N, Wang X, Kozono D, Watt C, Landrenau R, Wigle D, Port J, Jones DR, Conti M, Ashrafi AS, Liberman M, Yasufuku K, Yang S, Mitchell JD, Pass H, Keenan R, Bauer T, Miller D, Kohman LJ, Stinchcombe TE, Vokes E. Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Feb 9;388(6):489-498. doi: 10.1056/NEJMoa2212083. PMID 36780674
• Jones GD, Tan KS, Caso R, Dycoco J, Park BJ, Bott MJ, Molena D, Huang J, Isbell JM, Bains MS, Jones DR, Rocco G. Time-varying analysis of readmission and mortality during the first year after pneumonectomy. J Thorac Cardiovasc Surg. 2020 Jul;160(1):247-255.e5. doi: 10.1016/j.jtcvs.2020.02.086. Epub 2020 Mar 7. PMID 32249082
• Shapiro M, Swanson SJ, Wright CD, Chin C, Sheng S, Wisnivesky J, Weiser TS. Predictors of major morbidity and mortality after pneumonectomy utilizing the Society for Thoracic Surgeons General Thoracic Surgery Database. Ann Thorac Surg. 2010 Sep;90(3):927-34; discussion 934-5. doi: 10.1016/j.athoracsur.2010.05.041. PMID 20732520
• Yang J, Xia Y, Yang Y, Ni ZZ, He WX, Wang HF, Xu XX, Yang YL, Fei K, Jiang GN. Risk factors for major adverse events of video-assisted thoracic surgery lobectomy for lung cancer. Int J Med Sci. 2014 Jun 11;11(9):863-9. doi: 10.7150/ijms.8912. eCollection 2014. PMID 25013365
• Kozower BD, Sheng S, O'Brien SM, Liptay MJ, Lau CL, Jones DR, Shahian DM, Wright CD. STS database risk models: predictors of mortality and major morbidity for lung cancer resection. Ann Thorac Surg. 2010 Sep;90(3):875-81; discussion 881-3. doi: 10.1016/j.athoracsur.2010.03.115. PMID 20732512
• Pricopi C, Mordant P, Rivera C, Arame A, Foucault C, Dujon A, Le Pimpec Barthes F, Riquet M. Postoperative morbidity and mortality after pneumonectomy: a 30-year experience of 2064 consecutive patients. Interact Cardiovasc Thorac Surg. 2015 Mar;20(3):316-21. doi: 10.1093/icvts/ivu417. Epub 2014 Dec 8. PMID 25487232

Identifiers

NCT: NCT06534489 · RTS-021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗