Non-small cell lung cancer
Conditions
Interventions
Segmentectomy
Sponsors
Tsutani Yasuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at the first registration 1) Definitive diagnosis of non-small cell lung cancer is obtained by histology, biopsy, or cytology from the primary tumor or lymph nodes. 2) Diagnosed as resectable clinical stage II-III (UICC-TNM classification 9th edition) based on contrast-enhanced chest CT, PET/CT, and contrast-enhanced brain MRI or CT, and received at least 1 and up to 4 courses of neoadjuvant chemoimmunotherapy. 3) Meets all of the following conditions on contrast-enhanced chest CT or PET/CT performed after neoadjuvant chemoimmunotherapy: (a) For the primary tumor, meets all of the following: i) The entire residual tumor and scar tissue are deemed resectable by segmentectomy. ii) No invasion to the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina, and no satellite tumor nodules in a different ipsilateral lobe. iii) Not an apical chest wall invading cancer (superior sulcus tumor). iv) The primary site of the tumor is not in the middle lobe. (b) For regional lymph nodes, ycN0. 4) Aged 18 years or older at the time of informed consent for the first registration. 5) Written informed consent is obtained from the patient after adequate explanation of the study contents prior to enrollment. 6) The patient tolerates lobectomy and meets all the following. Respiratory function tests should use the latest values after neoadjuvant chemoimmunotherapy. (Resting SpO2 should use the latest value within 28 days prior to the first registration. A test on the same day of the week 4 weeks prior to the first registration date is acceptable.) (a) Predicted postoperative FEV1.0 >= 800 mL (b) Preoperative resting SpO2 >= 93% (room air). If the resting SpO2 is = 65 mmHg (room air). 7) Performance status (ECOG) is 0 or 1. 8) Meets all of the following conditions. (All laboratory tests should use the latest values obtained after neoadjuvant therapy and within 28 days prior to the first registration. A test on the same day of the week 4 weeks prior to the first registration date is acceptable.) (a) White blood cell count >= 3,000 /mm3 (b) Hemoglobin >= 8.0 g/dL (c) Platelet count >= 100,000 /mm3 (d) AST <= 100 IU/L (e) ALT <= 100 IU/L (f) Total bilirubin <= 2.0 mg/dL (g) Serum creatinine <= 2.0 mg/dL 9) No history of ipsilateral thoracic surgery with the following exceptions: (a) Thoracoscopic resection of a bulla (b) Thoracoscopic surgery without resection of the lung, esophagus, and mediastinum (e.g., pleural biopsy) (c) Wedge resection 10) No history of any drug therapy other than endocrine therapy (cytotoxic anticancer drugs, molecular targeted drugs, or immune checkpoint inhibitors) within the past 2 years, including treatment for other types of cancer. (Except for neoadjuvant chemoimmunotherapy for the current lung cancer) 11) No history of radiotherapy to the chest (lung, hilum, or mediastinum) for other cancers. Inclusion criteria at the second registration 1) The patient has been registered in the first registration of this study, and the second registration date is within 42 days of the first registration. (The same day of the week 6 weeks later is acceptable) 2) The entire residual tumor and scar tissue are technically deemed amenable to complete resection by segmentectomy. 3) The patient does not have lymph node inflammatory changes (adherence to pulmonary vessels or bronchi) or extranodal extension, and d
Exclusion criteria
Exclusion criteria: Exclusion criteria at the first registration 1) Hilar lymph node enlargement with extranodal extension observed on chest CT or bronchoscopy performed prior to neoadjuvant chemoimmunotherapy. 2) Active synchronous or metachronous (disease-free interval within 2 years) double/multiple cancers. (However, even if the disease-free interval is less than 2 years, a history of cancers with an equivalent 5-year relative survival rate of >= 95%, such as clinical stage I prostate cancer, clinical stage 0 or I laryngeal cancer that achieved a complete response by radiotherapy, or completely resected cancers of the following pathological stages, are not considered active double/multiple cancers: Gastric cancer [adenocarcinoma (common type)]: stage 0-I; Colon cancer [adenocarcinoma]: stage 0-I; Rectal cancer [adenocarcinoma]: stage 0-I; Esophageal cancer [squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma]: stage 0; Breast cancer [ductal carcinoma in situ, lobular carcinoma in situ]: stage 0; Breast cancer [invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease]: stage 0-IIA; Endometrial cancer [endometrioid adenocarcinoma, mucinous adenocarcinoma]: stage I; Prostate cancer [adenocarcinoma]: stage I-II; Cervical cancer [squamous cell carcinoma]: stage 0; Thyroid cancer [papillary carcinoma, follicular carcinoma]: stage I, II, III; Renal cell carcinoma [clear cell carcinoma, chromophobe cell carcinoma]: stage I; and other lesions equivalent to intramucosal carcinoma). 3) Active systemic infectious disease requiring treatment (having a fever of >= 38.0C and bacterial infection proven by imaging or bacteriological examination). 4) Women who are pregnant, breastfeeding, or of childbearing potential. 5) Clinically significant psychiatric disorders that make participation in the study difficult. 6) Continuous systemic administration of steroids or immunosuppressive drugs. 7) History of severe hypersensitivity. 8) Exclusion criteria related to comorbidities: (a) Complicated by interstitial pneumonia or pulmonary fibrosis. (b) Poorly controlled diabetes mellitus. (c) Poorly controlled hypertension. (d) History of unstable angina (angina that developed or worsened within the last 3 weeks) or a myocardial infarction within 6 months. (e) Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 9) Other cases judged inappropriate by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of pathological complete resection by segmentectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, Overall survival, Proportion of pathological complete resection by segmentectomy according to pathological response, Cumulative incidence of local recurrence, Cumulative incidence of distant recurrence, Proportion of pathological complete resection and surgical procedures in the first-registered patients, Dropout rate between the first and second registration, Postoperative pulmonary function (at 6 and 12 months postoperatively), Number of resected segments, Operative time, Blood loss, Incidence of adverse events, Incidence of serious adverse events | — |
Contacts
Public ContactAtsushi Kamigaichi
Hiroshima University Hospital
Outcome results
None listed