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JCOG2109: Anatomical segmentectomy versus wedge resection for small (<=2 cm) peripheral non-small cell lung cancer in 80 or more aged elderly patients: a randomized phase III study (AWESOME)

JCOG2109: Anatomical segmentectomy versus wedge resection for small (<=2 cm) peripheral non-small cell lung cancer in 80 or more aged elderly patients: a randomized phase III study (AWESOME)

SAJI Hisashi

St.Marianna University School of Medicine

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa

saji-q@ya2.so-net.ne.jp

NOGUCHI Umi

St.Marianna University School of Medicine

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa

+81-44-977-8111

umi-n@marianna-u.ac.jp

Recruiting

Dec. 02, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Primary enrollment eligibility criteria
(1) All of the following are met by contrast-enhanced CT, thin slice CT of the chest, FDG-PET/CT, and contrast-enhanced CT of the brain or MRI.
(i) Suspected non-small cell lung cancer of clinical stage T1miabN0M0.
(ii) Tumor center is located in the peripheral lung field (mantle one-third).
(iii) Whole tumor size is 2 cm or smaller.
(iv) Solid predominant tumor (C/T ratio > 0.5).
(v) 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 primary enrollment.
(4) 80 years or older.
(5) Performance status is 0 or 1 according to ECOG criteria.
(6) No history of any drug therapy other than endocrine therapy (cytotoxic anticancer drugs, molecular targeted drugs, or immune checkpoint inhibitors) within 2 years, including treatment for other types of cancer.
(7) If there is a history of radiotherapy including other types of cancer, the thoracic region (lung, hilar region, mediastinum) is not included in the irradiation field.
(8) The patient tolerate lobectomy. All of the following are met.
(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 mmHg.
(9) No interstitial pneumonia or pulmonary fibrosis as diagnosed by chest CT.
(10) Either (i) or (ii) of modified MRC is met.
(i) Modified MRC is Grade 0 or 1 (echocardiography is not required).
(ii) Modified MRC is Grade 2 and left ventricular ejection fraction exceeds 40% on echocardiography.
(11) Patient meets either (i), (ii), or (iii) regarding the latest resting 12-lead ECG.
(i) No ischemic changes, atrial fibrillation, atrial flutter, two or more consecutive premature ventricular contraction, newly emerged complete left bundle branch block, or pacemaker rhythm.
(ii) If ischemic changes are present, echocardiography and exercise stress echocardiography are performed, and it is determined that treatment for ischemic heart disease is not warranted.
(iii) In the presence of atrial fibrillation, atrial flutter, two or more consecutive premature ventricular contraction, newly emerging complete left bundle branch block, or pacemaker tuning, echocardiography is performed and left ventricular ejection fraction exceeds 40%.
(12) The most recent laboratory data within 28 days prior to primary enrollment (the same day of the week 4 weeks prior to the primary enrollment date is acceptable) meet all of the following.
(i) White blood cell count >= 3,000/mm3
(ii) Hemoglobin >= 8.0 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 <= 2.5 mg/dL
(v) AST <=100 U/L
(vi) ALT<=100 U/L
(vii) Serum creatinine <= 2.0 mg/dL
(13) Written consent to participate in the study has been obtained from the patient.

Secondary (intraoperative) enrollment eligibility criteria
(1) Primary enrollment in the study and the secondary enrollment date is within 28 days of the primary enrollment date (the same day of the week 4 weeks later is acceptable).
(2) Preoperative or intraoperative pathology (wedge resection 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) 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 wedge resection.
(4) 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 adjacent lungs.
If (i)-(iii) are suspected grossly, each specimen should be submitted to frozen section and confirmed negative for metastasis by rapid pathological diagnosis.

(1) Active multiple cancers (synchronous double cancers / multiple cancers and metachronous double cancers / multiple cancers with disease-free period of 3 years or less.
(2) Infectious disease requiring systemic treatment.
(3) Body temperature >= 38.0C at the time of enrollment.
(4) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult.
(5) Receiving continuous systemic administration (oral or intravenous) of steroids (more than 10 mg/day of prednisone equivalent) or other immunosuppressive drugs.
(6) Uncontrolled diabetes mellitus (HbA1c > 8%).
(7) Uncontrolled hypertension.
(8) Unstable angina (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within 6 months.
(9) Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.

Both

Non-small cell lung cancer

Arm A: Segmentectomy
Arm B: Wedge resection

Overall survival

Recurrence-free survival, cumulative incidence of death due to other causes, incidence of local recurrence, incidence of complications of Clavien-Dindo Classification Grade 2 or higher (within 30 and 90 days after surgery), postoperative pulmonary function (6 months and 1 year after surgery), proportion of non-adverse events in geriatric IADL, proportion of intraoperative adverse events, operation time, blood loss, drainage duration, length of postoperative hospital stay, and number of surgery-related deaths within 30 and 90 days after surgery.

+81-3-3542-2511

Oct. 19, 2022

No

none