clinical stage IA non-small cell lung cancer
Conditions
Interventions
A:Wedge resection
B:Anatomical segmentectomy
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at primary registration (1)Fulfills all the following conditions on imaging studies (i)cT1N0M0 NSCLC is suspected (ii)Center of the tumor is located in the outer third of the lung field. (iii)Maximum diameter of the tumor <= 3 cm (iv)C/T ratio is > 0.5 (2)No satellite tumors (3)Fulfills the definition for high-risk in lung lobectomy (fulfills more than one major criterion or more than 2 minor criteria) Major criteria (a)%FEV1 <= 50% (b)%DLCO <= 50% Minor criteria (c)Aged 75 years or older (d)%FEV1 > 50% and %FEV1 <= 60% (e)%DLCO > 50% and %DLCO <= 60% (f)Pulmonary hypertension (g)Left ventricular dysfunction (h)PaO2 <= 55 mmHg or SpO2 <= 88% (i)PaCO2 > 45 mmHg (j)Modified Medical Research Council Dyspnea Scale grade 3 or higher (4)Negative for neuroendocrine tumor if cytology tests are performed (5)Aged 20 years or older (6)PS of 0 to 1 (7)No prior medical treatment for any type of tumor in the past 2 years (hormone therapy is allowed) (8)No prior radiation therapy on the lungs, hilum or mediastinum (9)Fulfills both of the following conditions (i)Predicted postoperative %FEV1 >= 30% (ii)Predicted postoperative %DLCO >= 30% (10)Sufficient organ function. (All test results must be obtained within 28 days before enrollment.) (i)White blood cell count >= 3,000/mm3 (ii)Hemoglobin >= 8.0 g/dL (iii)Platelet count >= 100,000/mm3 (iv)Total bilirubin <= 2.0 mg/dL (v)AST <= 100 U/L (vi)ALT <= 100 U/L (vii)Creatinine <= 1.5 mg/dL (11)No sign of ischemia on latest ECG. (12)Written informed consent. Secondary registration (intraoperative) criteria (1)Within 14 days of the primary registration (2)Histological confirmation of NSCLC before surgery or during surgery by diagnostic wedge resection or needle biopsy. (3)Technically possible to perform wedge resection and anatomical 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) Active infection requiring systemic therapy. (3) Fever of higher than 38.0 degrees Celsius at the time of enrollment. (4) Pregnant, possibly pregnant, within 28 days after delivery, breastfeeding female or males expecting conception of their child. (5) Psychiatric illnesses or symptoms affecting daily lives. (6) Systemic administration of steroids or immunosuppressive agents either orally or intravenously. (7) Uncontrollable diabetes (HbA1c > 8%). (8) Uncontrollable hypertension. (9) Unstable angina (diagnosis or worsening of chest pain within 3 weeks) or history of myocardial infarction within 6 months prior to enrollment. (10) Uncontrollable heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (11) Diagnoses of interstitial pneumonia, pulmonary fibrosis, or both, on chest CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, postoperative respiratory function, relapse-free survival, proportion of local recurrences, operation time, blood loss. | — |
Countries
Japan
Contacts
Public ContactYasuhiro Tsutani
JCOG1909 Coordinating Office Surgical Oncology, Hiroshima University Hospital
Outcome results
None listed