JCOG2217: Lobectomy versus segmentectomy in patients with radiological solid-predominant non-small cell lung cancer with a ground-glass opacity component (>2-3 cm in maximum tumor size): phase III randomized trial

JRCT ID: jRCT1030240027

Registered date:12/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 12/04/2024
• Target sample size: 515
• Study type: Interventional

Intervention(s)

Arm A: Lobectomy
Arm B: Segmentectomy

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Recurrence-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, adverse events, and proportion of surgery-related deaths within 30 and 90 days after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

The first registration inclusion criteria
(1) Contrast-enhanced CT, thin slice CT of the chest, FDG-PET/CT, and contrast-enhanced CT of the brain or MRI should detect all of the following.
(i) Suspected non-small cell lung cancer of clinical stage T1bcN0M0.
(ii) More than 2 cm and less than 3 cm at the whole tumor size.
(iii) Solid predominant tumor (consolidation/tumor ratio > 0.5). If consolidation/tumor = 1.0, tumors with ground-glass opacity on thin slice CT of the chest are eligible.
(iv) Not a pure-solid tumor without ground-glass opacity.
(v) A surgical margin to the tumor estimated on a preoperative chect CT to be more than 2 cm.
(vi) Tumor center is located in the peripheral lung field (mantle one-third).
(vii) The primary site of the tumor is not in the middle lobe.
(2) No secondary tumor.
(3) No confirmed diagnosis of neuroendocrine tumor if histopathology or cytology was performed prior to the first registration.
(4) Aged 18 to 85 years old on the day of the registration.
(5) Performance status of ECOG is 0 or 1.
(6) No history of any drug therapy other than endocrine therapy (cytotoxic anticancer drugs, molecular targeted drugs, or immune checkpoint inhibitors) within 5 years, including treatment for other types of cancer.
(7) No history of previous thoracic surgery with the exception of the following:
(i) Thoracoscopic resection of a bulla.
(ii) Thoracoscopic surgery without resection of the lung, esophagus, and mediastinum.
(iii) Wedge resection of a benign tumor on the contralateral side.
(8) No history of radiotherapy to the lung, hilum, or mediastinum for other cancers.
(9) The patient tolerates lobectomy and meets all of the following.
(i) Predicted postoperative volume in 1 second (ppoFEV1.0) is >= 800 mL.
(ii) Preoperative resting SpO2 >= 92%. If the resting SpO2 is < 92%, PaO2 is >= 65 torr.

(10) The latest blood examination result within 28 days prior to the first registration (the same day of the week 4 weeks before the registration is acceptable) meets all of the following.
(i) White blood cell count >= 3,000/mm3
(ii) Hemoglobin >= 9.0 g/dL (no blood transfusion within 14 days prior to the blood draw for the test used for registration)
(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
(11) Written consent to participate in the study has been obtained from the patient.

The second registration inclusion criteria
(1) The second registaration date is within 28days of the first registaration date is within 28 days (the same day of the week 4 weeks later is acceptable).
(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, adenosquamous carcinoma, sarcomatoid carcinoma, other epithelial tumor, salivary gland-type tumor, non-small cell carcinoma - NOS. Intraoperative frozen section is not required if the patient has a preoperative diagnosis of non-small cell lung cancer.
(3) No confirmed diagnosis of neuroendocrine tumor by preoperative or intraoperative pathology.
(4) 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.
(5) None of the following are present on intra-thoracic observation.
(i) malignant pleural effusion, (ii) pleural dissemination, (iii) regional lymph node metastasis, or (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.

Exclude criteria

(1) Synchronous or metachronous (within 2 years) malignancy, with the exception of intramucosal tumors curatively treated with local therapy.
(2) Infectious disease requiring systemic treatment.
(3) Body temperature >= 38.0C at the time of the registration.
(4) Female during pregnancy or lactation.
(5) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult.
(6) Receiving 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.

Related Information

• Primary Sponsor: SUZUKI Kenji
• Source(s) of Monetary Support: National Cancer Center Japan