pathological N2 non-small cell lung cancer
Conditions
Interventions
A: Observation
B: Thoracic radiotherapy
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically confirmed NSCLC via surgical specimens (2)Diagnosed as clinical N0-1 prior to surgery but diagnosed as pathological N2 after surgery (3)Complete resection (R0) is histologically confirmed via surgical specimens (4)No satellite tumors (5)Lobectomy is performed for the primary tumor (6)Systematic or lobe-specific lymph node dissection is performed (7)Aged 20 years or older at the time of registration (8)Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (9)No prior segmentectomy or lobectomy of the lung other than the resection of the primary tumor (10)No prior chemotherapy other than the postoperative chemotherapy for the primary tumor (11)No prior radiotherapy to the chest (12)More than one course of any of the following regimens is administered for the postoperative chemotherapy without Grade 4 non-hematologic adverse events or drug-induced pneumonitis (a)Cisplatin plus vinorelbine (b)Cisplatin plus docetaxel (c)Cisplatin plus pemetrexed (13)Within 56 days after postoperative chemotherapy for the primary tumor (14)No sign of relapse on head, thoracic, and abdominal contrast-enhanced CT after completion of postoperative chemotherapy (15)No sign of interstitial pneumonia on CT and by histological evaluation of the surgical specimen (16)Can undergo radiotherapy according to the protocol (17)Sufficient organ function (a)White blood cell count >= 3,000/mm3, <= 12,000/mm3 (b)Hemoglobin >= 9.0g/dL (c)Platelet count >= 80,000/mm3 (d)Total bilirubin <= 1.5 mg/dL (e)Aspartate aminotransferase <= 100 U/L (f)Alanine aminotransferase <= 100 U/L (g)Creatinine <= 1.5 mg/dL (h)SpO2 >= 93% (room air) (18)No sign of ischemic heart disease on the latest electrocardiogram findings (19)Written informed consent
Exclusion criteria
Exclusion criteria: (1)History of synchronous or metachronous (within 3 years) malignancies (2)Active infection requiring systemic therapy (3)Fever with a body temperature higher than 38.0 degrees Celsius at the time of registration (4)Pregnant, possibly pregnant, within 28 days of delivery, breastfeeding females, or males expecting to father a child (5)Psychiatric illnesses or symptoms affecting the daily lives (6)Systemic treatment with steroids or immunosuppressive agents (7)Unstable angina(diagnosis or worsening of chest pain within 3 weeks) or history of myocardial infarction within 6 months prior to the registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, proportion of patients completing radiotherapy in arm B, early adverse events, late adverse events in arm B, severe adverse events, local recurrence | — |
Countries
Japan
Contacts
Public ContactKazuo Nakagawa
JCOG1916 Coordinating Office Division of Thoracic Surgery, National Cancer Center Hospital
Outcome results
None listed