Clinical stage IA non-small cell lung cancer, radiologically noninvasive lung cancer
Conditions
Interventions
A: Watchful waiting until the lesion meets the resection criteria (follow-up with chest thin-section CT every 6 months for the first 3 years and every year for the next 10 years after registration)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at primary registration (1)Fulfills all the following conditions on chest thin-section CT (i)cN0M0 NSCLC is suspected (ii)Within 3 lesions (Bilateral lesions are allowed) (iii)Maximum diameter of the tumor <= 2 cm and C/T ratio <= 0.25 (iv)Pure-GGN with maximum diameter of the tumor <= 1 cm is ineligible (v) Not adjacent to the pleura (vi)No pleural indentation (vii) No chest thin-section CT has been performed prior to 168 days (24 weeks) of registration (2)Aged 20 to 79 years old (3)PS of 0 to 1 (4)No prior medical treatment for any type of tumor (hormone therapy and Pre- and postoperative adjuvant chemotherapy are allowed) and no prior radiation therapy on the lungs, hilum or mediastinum (5)Fulfills both of the following conditions (i)Predicted postoperative FEV1 >= 800ml (ii)SpO2 >= 93% (6)Sufficient organ function (All test results must be obtained within 28 days before enrollment) (i)White blood cell count >= 3,000/mm3 (ii)Hemoglobin >= 8.0 g/dL (iii)Platelet count >= 100,000/mm3 (iv)Total bilirubin <= 2.0 mg/dL (v)AST <= 100 U/L (vi)ALT <= 100 U/L (vii)Creatinine <= 1.5 mg/dL (7)Written informed consent Secondary registration criteria (1)Within 196 days of the primary registration (2) No tumor regression or enlargement between the initial and second thin-section chest CT {The second CT is taken between 84 days (12 weeks) and 140 days (20 weeks) after the date of the initial CT} (3) Within 56 days (8 weeks) of the second CT
Exclusion criteria
Exclusion criteria: (1)History of synchronous or metachronous (within 5 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis (2)Active infection requiring systemic therapy (3)Fever of higher than 38.0 degrees Celsius at the time of enrollment (4)Pregnant, possibly pregnant, within 28 days after delivery, breastfeeding female or males expecting conception of their child (5)Psychiatric illnesses or symptoms affecting daily lives (6)Systemic administration of steroids or immunosuppressive agents either orally or intravenously (7)Uncontrollable diabetes (8)Uncontrollable hypertension (9)Unstable angina (diagnosis or worsening of chest pain within 3 weeks) or history of myocardial infarction within 6 months prior to enrollment (10)Uncontrollable heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy (11)Diagnoses of interstitial pneumonia, pulmonary fibrosis, or both, on chest CT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival, 5- and 10-year operation-free survival, 5- and 10-year extensive lung resection rate, 5- and 10-year unresectable progression rate, 5- and 10-year lung cancer specific survival, adverse events | — |
Countries
Japan
Contacts
Public ContactTomohiro Miyoshi
JCOG1906 Coordinating Office Division of Thoracic Surgery, National Cancer Center Hospital East
Outcome results
None listed