small (2 cm or less) peripheral radiological non-invasive lung cancer
Conditions
Interventions
Limited pulmonary resection
Sponsors
Japan Clinical Oncology Group(JCOG)
West Japan Oncology Group (WJOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Contrast-enhanced thoracic CT fulfills all of the following conditions: i) lung cancer is suspected, ii) the number of tumor is three or less, iii) center of tumor is located in the outer third of the lung field, iv) no lymph node metastasis. 2) Thin-section CT fulfills both of the following conditions: i) all tumors are diagnosed as radiological non-invasive cancer, ii) maximum diameter of any tumor is 2 cm or less. 3) In case pathological or cytological examination is performed preoperatively, pathological diagnosis of the tumor fulfills both of the following conditions: i) lung adenocarcinoma is suspected (including atypical adenomatous hyperplasia). ii) all tumors are not diagnosed as being tumor other than adenocarcinoma. 4) Aged 20 to 79 years old. 5) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed). 6) No prior chemotherapy or radiation therapy for any malignant diseases (prior hormonal therapy is allowed). 7) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. 8) Performance status of 0 or 1. 9) Sufficient organ functions. 10)Written informed consent.
Exclusion criteria
Exclusion criteria: 1) simultaneous or metachronous (within the past 5 years) double cancers. 2) interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema. 3) active bacterial or fungous infection. 4) women during pregnancy or breast-feeding. 5) psychiatric disease. 6) systemic steroids 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 or attack of angina pectoris within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, proportion of local recurrence, postoperative respiratory function, proportion of completion of limited resection, adverse events. | — |
Countries
Japan
Contacts
Public ContactKenji Suzuki
JCOG0804 Study Coordinating Office Division of Thoracic Surgery, Juntendo University
Outcome results
None listed