3cm or less lung cancer dominant with ground glass opacity
Conditions
Interventions
Lung segmentectomy
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Contrast-enhanced computed tomographic findings fulfill all of the following conditions: i) lung cancer is suspected (excluding right middle lobe lung cancer). ii) no lymph node metastasis (cN0). iii) surgical margin is estimated on preoperative thin-section computed tomography (TSCT) to be more than 2cm or tumor diameter. 2) TSCT findings of the main tumor fulfill any of the following conditions: i) 2cm< tumor diameter =<3cm and a consolidation/tumor (C/T) ratio =<0.5. ii) tumor diameter =<2cm and 0.25< C/T ratio =<0.5. iii) tumor diameter =<2cm, C/T ratio =<0.25 and center of tumor is not located in the outer third of the lung field. 3) The number of additional tumors is 2 or less on TSCT. TSCT findings of the additional tumors fulfill any of the following conditions: i) tumor diameter =<2cm, C/T ratio =<0.25, and center of tumor is located in the outer third of the lung field. ii) pure ground glass nodules =<10mm 4) Totally resectable in one stage of one segmentectomy and two or less wedge resections. 5) In case pathological or cytological examination is performed preoperatively, tumor is diagnosed as lung adenocarcinoma pathologically or suspected as lung adenocarcinoma clinically. 6) Aged 20 to 79 years old. 7) No prior affected thoracotomy or thoracoscopic surgery (prior diagnostic thoracoscopy is allowed). 8) No pulmonary resection excluding wedge resection on the unaffected side. 9) No prior chemotherapy or thoracic radiation therapy for any malignant diseases (prior hormonal, neo-adjuvant, or adjuvant therapy is allowed). 10) In case prior thoracic radiation therapy is performed, meet all the following criteria, i) the hilum or mediastinum of affected side were excluede from radiation field. ii) No prior radiation pneumonitis of affected side. 11) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. 12) Performance status of ECOG 0 or 1. 13) Sufficient organ functions. 14) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) simultaneous or metachronous (within the past 5 years) double cancers other than carcinoma in situ or mucosal carcinoma. 2) active infection requiring treatment. 3) fever higher than 38 degrees C in axillary temperature. 4) women during pregnancy, possibility of pregnancy, or breast-feeding. 5) psychiatric disease. 6) systemic steroids or immunosuppressive medication. 7) diabetes mellitus treated with insulin or poorly controlled. 8) poorly controlled hypertension. 9) history of severe heart disease, heart failure, myocardial infarction within the past 6 months, attack of angina pectoris within the past 6 months, or multiple cardiac histories. 10) interstitial pneumonitis, pulmonary fibrosis, severe pulmonary emphysema, or multiple pulmonary comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, relapse-free survival, proportion of local recurrence, postoperative respiratory function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, incidence of adverse events, incidence of severe adverse events | — |
Countries
Japan
Contacts
Public ContactKeiju Aokage
JCOG1211 Coordinating Office Division of Thoracic Surgery, National Cancer Center Hospital East
Outcome results
None listed