Clinical stage I/II non-small cell lung cancer except for the following
Conditions
Interventions
A: Upper or lower lobectomy plus systematic nodal dissection
B: Upper or lower lobectomy plus lobe-specific nodal dissection
C: Middle lobectomy plus systematic nodal dissection
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First registration (preoperative) criteria 1) Tumor suspected of lung cancer on thoracic CT 2) No additional tumor nodule in different lobe from primary tumor 3) Clinical stage I/II except for the following conditions (UICC-TNM ver. 8) i) Maximum diameter of the tumor including GGA is <= 2cm and cN0 ii) GGA-dominant (Consolidation/Tumor ratio<= 0.5) and maximum diameter of the tumor is > 2-3cm and cN0 iii) cT3N0 with direct invasion to chest wall, phrenic nerve, and pericardium iv) cN1 with extranodal invasion (defect image in bronchial and vascular walls) 4) No neuroendocrine tumors 5) Aged 20 to 79 years old 6) ECOG performance status of 0 or 1 7) No following surgical history i) Ipsilateral thoracotomy ii) Ipsilateral thoracoscopic resection of lung, esophagus, and mediastinum (except for thoracoscopic resection of bullae) iii) Contralateral thoracotomy or thoracoscopic surgery except for wedge resection of the lung 8) No prior chemotherapy (prior postoperative adjuvant chemotherapy and hormone therapy are allowed) 9) No prior radiotherapy fulfilling the following condition i) Radiotherapy to ipsilateral hilum and mediastinum ii) Ipsilateral radiation pneumonitis (>= grade 2) 10) Expected postoperative FEV1.0>=800 mL and SpO2>=93% (room air). 11) Technically possible to perform all resections (lobectomy, lobectomy plus one segmentectomy, or lobectomy plus <=2 wedge resections) at a time 12) Sufficient organ functions 13) Written informed consent Second registration (intraoperative) criteria 1) Within 14 days of the first registration 2) Histologically confirmed NSCLC 3) Technically possible to perform lobectomy and lymph node dissection 4) No malignant effusion, dissemination, hilar (#10, #11) / mediastinal node metastasis, and direct invasion into surrounding organs except for adjacent lobe macroscopically 5) Negative hilar (#10, #11) node on frozen section for cN1 tumor suspected of hilar (#10, #11) node metastasis preoperatively
Exclusion criteria
Exclusion criteria: 1) Synchronous double/multiple cancer or metachronous double/multiple cancer with disease-free period of 5 years or shorter, except for following;; prostate cancer with clinical stage I and completely resected following cancers; gastric cancer (adenocarcinoma) with stage 0-I, colon cancer (adenocarcinoma) with stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) with stage 0, breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma) with stage 0 and breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget disease) with stage 0-IIA, endometrial cancer (endometrioid adenocarcinoma and mucinous adenocarcinoma) with stage I, prostate cancer (adenocarcinoma) with stae I-II, cervical cancer (squamous cell carcinoma) with stage 0, thyroid cancer (papillary carcinoma and follicular carcinoma) with stage I-III, and renal cancer (clear cell carcinoma and chromophobe cell carcinoma) with stage I. 2) Active infection requiring systemic therapy. 3) Fever of 38 degree or higher at registration 4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 5) Severe psychological disorder 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) Insulin-dependent or 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. 10) Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, proportion of local recurrence, proportion of local lymph node recurrence, operation time, blood loss, length of hospitalization, duration of chest tube placement, adverse events, serious adverse events. | — |
Countries
Japan
Contacts
Public Contact(2)Hisashi Saji (1)Tomoyuki Hishida
JCOG1413 Coordinating Office (1)Keio University School of Medicine (2)St. Marianna University School of Medicine
Outcome results
None listed