small (2 cm or less) peripheral non-small cell lung cancer
Conditions
Interventions
A: Pulmonary lobectomy
B: Pulmonary segmentectomy
Sponsors
Japan Clinical Oncology Group(JCOG)
West Japan Oncology Group (WJOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preoperative criteria, 1) Contrast-enhanced thoracic CT fulfills all of the following conditions: i) single tumor, ii) non-small cell lung cancer is suspected, iii) Center of tumor is located in the outer third of the lung field, iv) the tumor is not located at middle lobe, v) no lymph node metastasis. 2) Thin-section CT fulfills both of the following conditions: i) maximum diameter of the tumor is 2 cm or less, ii) the proportion of maximum diameter of the tumor itself to consolidation is more than 0.5. 3) Aged 20 to 79 years old. 4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed). 5) No prior chemotherapy or radiation therapy for any malignant diseases. 6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. 7) Performance status of 0 or 1. 8) Sufficient organ functions. 9) preoperative body temperature is 38C or less 10)Written informed consent. Intraoperative criteria, 1) the date of surgery (second registration) is within 28 days of the first registration, 2) histologically confirmed either adenocarcinoma, adenosquamous carcinoma, large cell carcinoma, or non-small cell lung cancer (detailed category unknown), 3) neither malignant pleural effusion nor pleural dissemination, 4) no lymph node metastasis 5) technically possible to perform any of the following procedures: lobectomy, segmentectomy, and nodal dissection.
Exclusion criteria
Exclusion criteria: 1) Active bacterial or fungous infection. 2) Simultaneous or metachronous (within the past 5 years) double cancers. 3) Women during pregnancy or breast-feeding. 4) Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema. 5) Psychosis. 6) Systemic steroids medication. 7) Uncontrollable diabetes mellitus. 8) Uncontrollable 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 |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| postoperative respiratory function, relapse-free survival, proportion of local recurrence, adverse events, proportion of completion of segmentectomy, days of hospitalization, duration of chest tube placement, operation time, blood loss, number of used auto-sutures. | — |
Countries
Japan
Contacts
Public ContactMasahiro Tsuboi / Hisashi Saji
JCOG0802 Study Coordinating Office Division of Thoracic Surgery, Kanagawa Cancer Center/St. Marianna University School of Medicine Hosp
Outcome results
None listed