JCOG2501: Lobectomy versus segmentectomy for centrally located, small-sized (<=2 cm), and radiologically solid-dominant non-small cell lung cancer : a phase III randomized controlled trial
(UNLIMITED)
JCOG2501: Lobectomy versus segmentectomy for centrally located, small-sized (<=2 cm), and radiologically solid-dominant non-small cell lung cancer : a phase III randomized controlled trial
(UNLIMITED)
OKADA Morihito
Hiroshima University Hospital
1-2-3. Kasumi,Minami-ku, Hiroshima, Japan
+81-82-257-5869
morihito1217@gmail.com
TSUBOKAWA Norifumi
Hiroshima University Hospital
1-2-3. Kasumi,Minami-ku, Hiroshima, Japan
+81-82-257-5869
international-1@hotmail.co.jp
Recruiting
Feb. 12, 2026
550
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
Inclusion criteria at the first registration
(1) Contrast-enhanced CT, thin slice CT of the chest, FDG-PET/CT, and contrast-enhanced CT or MRI of the brain should detect the following.
(i) Suspected non-small cell lung cancer of clinical stage T1miabN0M0.
(ii) Tumor center is located in the central lung field on a preoperative chest CT.
(iii) A surgical margin to the tumor estimated to be more than the tumor size on a preoperative chect CT or 3DCT.
(iv) Less than 2 cm in the whole tumor diameter.
(v) Solid predominant tumor (0.5 < consolidation/tumor ratio <= 1).
(vi) The primary site of the tumor is not in the middle lobe.
(2) No secondary tumor.
(3) Aged 18 to 85 years old on the day of the registration.
(4) Performance status of ECOG is 0 or 1.
(5) No history of any drug therapy other than endocrine therapy (cytotoxic anticancer drugs, molecular targeted drugs, or immune checkpoint inhibitors) within the past 2 years, including treatment for other types of cancer.
(6) No history of ipsilateral thoracic surgery with the following exceptions:
(i) Thoracoscopic resection of a bulla.
(ii) Thoracoscopic surgery without resection of the lung, esophagus, and mediastinum.
(iii) Wedge resection.
(7) No history of radiotherapy to the lung, hilum, or mediastinum for other cancers.
(8) The patient tolerates lobectomy and meets all the following.
(i) Predicted postoperative FEV1.0 is >= 800 mL.
(ii) Preoperative resting SpO2 >= 93%. If the resting SpO2 is < 93%, PaO2 is >= 65 torr.
(9) The latest blood examination result within 28 days prior to the first registration meets all of the following:
(i) White blood cell count >= 3,000/mm3
(ii) Hemoglobin >= 9.0 g/dL
(iii) Platelet count >= 100,000/mm3
(iv) Total bilirubin <= 1.5 mg/dL
(v) AST <=100 U/L
(vi) ALT<=100 U/L
(vii) Serum creatinine <= 1.5 mg/dL
(10) Written informed consent .
Inclusion criteria at the second registration
(1) The second registaration date is within 28days of the first registaration.
(2) Preoperative or intraoperative pathology (wedge resection, segmentectomy, or needle biopsy (cytology also acceptable)) diagnosed as adenocarcinoma in situ, adenocarcinoma, squamous cell carcinoma in situ, squamous cell carcinoma, large cell carcinoma, carcinoid/neuroendocrine tumor, large cell neuroendocrine carcinoma, adenosquamous carcinoma, sarcomatoid carcinoma, other epithelial tumor, salivary gland-type tumor, non-small cell carcinoma - NOS. An intraoperative frozen section is not required if the patient has a preoperative diagnosis of non-small cell lung cancer.
(3) The patient does not have severe adhesions, incomplete fissure, or lymph node inflammatory changes (adherence to pulmonary vessels or bronchi) and is technically deemed amenable to complete resection by either segmentectomy or lobectomy.
(4) None of the following are present on intra-thoracic observation.
(i) Malignant pleural effusion
(ii) Pleural dissemination
(iii) Regional lymph node metastasis
(iv) Involvement of adjacent organs except the adjacent lung
If (i)-(iii) are grossly suspected, each specimen should be submitted to frozen section and confirmed negative for metastasis by rapid pathologic diagnosis.
(1) Synchronous or metachronous (within 2 years) malignancy, with the exception of intramucosal tumors curatively treated with local therapy.
(2) Active infectious disease requiring systemic treatment at the time of registration.
(3) Body temperature >= 38.0C at the time of the registration.
(4) Women who are pregnant, breastfeeding, or of childbearing potential, and men who wish to conceive with their partners.
(5) Psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult.
(6) Continuous systemic administration (oral or intravenous) of steroids (more than 10 mg/day of prednisone equivalent) or other immunosuppressive drugs.
(7) Poorly controlled diabetes mellitus (HbA1c > 8%).
(8) Poorly controlled hypertension.
(9) History of unstable angina (angina that developed or worsened within the last 3 weeks) or a myocardial infarction within 6 months.
(10) Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(11) Severe emphysema, interstitial pneumonia, or pulmonary fibrosis based on chest CT.
18age old over
85age old under
Both
Non-small cell lung cancer
Arm A: Lobectomy
Arm B: Segmentectomy
Overall survival
Relapse-free survival, incidence of local recurrence, incidence of distant recurrence, cumulative incidence of death due to other causes, proportion of completion of segmentectomy, postoperative respiratory function, duration of surgery, amount of blood loss, incidence of severe adverse events within 30 and 90 days after surgery, and incidence of surgery-related deaths within 30 and 90 days after surgery
