clinical stage IA3 peripheral pure-solid non-small cell lung cancer
Conditions
Interventions
Pulmonary lobectomy
Pulmonary segmentectomy
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at primary registration 1) Fulfills all the following conditions on imaging studies (i) cT1cN0M0 (stage IA3) NSCLC is suspected (ii) Center of the tumor is located in the outer third of the lung field. (iii) Pure-solid tumor (C/T ratio = 1, the absence of ground-glass opacity) (iv) The tumor is not located at middle lobe. 2) No satellite tumors 3) Aged 18 years or older 4) Written informed consent 5) Fulfills both of the following conditions (i) Predicted postoperative FEV1.0 >= 800 mL (ii) Preoperative resting SpO2 >= 93%. If the resting SpO2 is <93%, PaO2 is >= 65 mmHg. 6) PS of 0 to 1 7) Sufficient organ function. (i) White blood cell count >= 3,000/mm3 (ii) Hemoglobin >= 8.0 g/dL (iii) Platelet count >= 100,000/mm3 (iv) AST <= 100 U/L (v) ALT <= 100 U/L (vi) Total bilirubin <= 2.0 mg/dL (vii) Creatinine <= 1.5 mg/dL 8) No prior ipsilateral pulmonary resection (prior diagnostic thoracoscopy is allowed). 9) No prior chemotherapy or radiation therapy for any malignant diseases within 2 years. (Hormone therapy is allowed) Inclusion criteria at Secondary registration (intraoperative) 1) Within 28 days of the primary registration 2) Histologically confirmed either adenocarcinoma, adenosquamous carcinoma, large cell carcinoma, sarcomatoid carcinoma, other epithelial tumors, salivary gland-type tumors, non-small cell lung cancer - NOS, large cell neuroendocrine carcinoma or carcinoid tumor. 3) Technically possible to perform lobectomy and segmentectomy. 4) No signs of malignant effusion, dissemination, regional lymph node metastasis, and direct invasion into surrounding organs except for adjacent lung regions.
Exclusion criteria
Exclusion criteria: 1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis. 2) Local or systemic active infection requiring treatment. 3) Pregnant, lactating, possibly currently pregnant. 4) Psychosis. 5) Systemic administration of steroids or immunosuppressive agents. 6) Patient who has severe drug allergy. 7) Comorbidities (i) Diagnoses of interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema. (ii) Uncontrollable diabetes (HbA1c > 8%). (iii) Uncontrollable hypertension. (iv) Unstable angina or history of myocardial infarction within 6 months prior to enrollment. (v) Uncontrollable heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse-free survival, postoperative respiratory function at 6 months and 1 year (FVC and FEV1.0), proportion of respiratory failure, proportion of cerebrovascular disease, cumulative incidence of death from other than primary lung cancer, cumulative incidence of local recurrence, proportion of patients who complete segmentectomy, number of resected segments, operative time, blood loss, adverse events. | — |
Countries
Japan
Contacts
Public ContactNaoki Ishizuka
West Japan Oncology Group WJOG datacenter
Outcome results
None listed