Resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis
Conditions
Interventions
A:lobectomy
B:Sublobar resection
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First registration (preoperative) criteria 1) Imaging findings fulfill all of the following conditions: i) T1a-2aN0M0 NSCLC suspected ii) Center of tumor located in the outer third of the lung field iii) Consolidation/Tumor ratio is > 0.5 if maximum diameter of the tumor is <= 3cm, iv) Maximum diameter of the tumor < 4 cm 2) No additional tumor nodule from primary tumor 3) All of the following conditions for idiopathic pulmonary fibrosis (IPF) are fulfilled: i) UIP pattern or possible UIP pattern in the high-resolution CT diagnosed by radiologists ii) %DLCO < 80 % iii) Interstitial lung disease (ILD) of unknown etiology iv) No history of acute exacerbation of IPF v) No history of systemic steroid for IPF 4) No neuroendocrine tumors 5) Aged 40 to 80 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 iii) Contralateral thoracotomy or thoracoscopic surgery except for wedge resection of the lung 8) No previous treatment of chemotherapy or endocrine therapy in five years 9) No prior radiotherapy to lung, ipsilateral hilum or mediastinum 10) Expected postoperative %FEV1.0 >= 30% and %DLCO >= 30% 11) Sufficient organ functions 12) No ischemic change on ECG 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 or wedge resection 4) No malignant effusion, dissemination, regional lymph node metastasis, and direct invasion into surrounding organs except for adjacent lobe macroscopically
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers 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) Uuncontrollable diabetes mellitus 8) Uncontrollable hypertension 9) Unstable angina, cardiac infarction within the past 6 months 10) Uncontrollable valvular disease or uncontrollable dilated cardiomyopathy or uncontrollable hypertrophic cardiomyopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, proportion of local recurrence, operation time, blood loss, proportion of acute exacerbation of IPF, postoperative respiratory function at 6 months and 1 year (FVC, FEV1.0 and %DLCO), adverse events, serious adverse events. | — |
Countries
Japan
Contacts
Public Contact(1)Yasuhiro Tsutani (2)Keiju Aokage
JCOG1708 Coordinating Office (1)Surgical Oncology, Hiroshima University Hospital (2)Division of Thoracic Surgery, National Cancer
Outcome results
None listed