JCOG2108: 非小細胞肺癌術後オリゴ再発に対する全身治療後の維持療法と局所療法を比較するランダム化比較第III相試験

試験ID jRCTs031230475

最終情報更新日：2024年12月19日

基本情報

• 試験ID: jRCTs031230475
• 研究名称 / Scientific Title（Acronym）: JCOG2108: 非小細胞肺癌術後オリゴ再発に対する全身治療後の維持療法と局所療法を比較するランダム化比較第III相試験
• 研究名称 / Scientific Title（Acronym）: JCOG2108: A multicenter randomized phase III study of systemic chemotherapy followed by maintenance therapy versus local consolidation therapy for postoperative oligometastatic recurrent non-small cell lung cancer
• 平易な研究名称 / Public Title（Acronym）: JCOG2108: A multicenter randomized phase III study of systemic chemotherapy followed by maintenance therapy versus local consolidation therapy for postoperative oligometastatic recurrent non-small cell lung cancer
• 試験進捗状況/Recruitment status: 参加者募集中
• 試験進捗状況/Recruitment status: Recruiting
• 登録日時: 2023年11月24日
• 最終情報更新日: 2024年12月19日

試験概要

• 試験実施地域 / Region: 日本
• 実施都道府県: 千葉県
• 目標症例数/Target sample size: 200
• 対象疾患 / Health condition(s) or Problem(s) studied: 非小細胞肺癌
• 対象疾患 / Health condition(s) or Problem(s) studied: Non-small cell lung cancere
• 試験のタイプ / Study type: 介入
• 試験のタイプ / Study type: Interventional

介入1

A群：導入療法→維持療法
B群：導入療法→根治的局所療法（手術または放射線治療）

介入2

A群：導入療法→維持療法
B群：導入療法→根治的局所療法（手術または放射線治療）

介入3

A群：導入療法→維持療法
B群：導入療法→根治的局所療法（手術または放射線治療）

介入4

A群：導入療法→維持療法
B群：導入療法→根治的局所療法（手術または放射線治療）

• 主要評価項目 / Primary outcomes: 全生存期間
• 主要評価項目 / Primary outcomes: Overall Survival
• 副次評価項目 / Secondary outcomes: Progression-free survival, Progression lesions (oligometastases, non-oligometastases), Oligometastases-free survival by type of local therapy, Adverse event rate, Severe adverse event rate, Quality of life (FACT-TOI, EQ-5D-5L )

適格性

• 年齢（下限）/ Age minimum: 18歳以上
• 年齢（下限）/ Age minimum: >= 18age old
• 年齢（上限）/ Age maximum: Not applicable
• 性別 / Gender: 男女両方
• 性別 / Gender: Both

選択基準 / Include criteria

Criteria for the primary registration
(1) Histologically completely resected non-small cell lung cancer.
(2) Ninety days or more have passed since theinitial lung resection, and more than 180 days* have passed since the definitive diagnosis of lung cancer.
* The date of diagnosis is the date of the imaging test if the diagnosis was made based on imaging tests, or the date of the biopsy if the diagnosis was made based on pathological tests. If the diagnosis was made based on multiple tests, the date of the earliest test is used.
(3) The initial pathological stage was I to III non-small cell lung cancer.
(4) If there is a history of postoperative adjuvant chemotherapy, including immune checkpoint inhibitors such as anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies, 180 days or more have passed since the last administration of postoperative adjuvant chemotherapy. The conditions is not applicable to UFT therapy.
(5) All of the examinations including contrast-enhanced neck to pelvic CT (*1), FDG-PET (PET/CT orPET/MRI), and contrast-enhanced brain MRI (*2) should fulfill all of the following criteria for oligometastases:
*1 If the use of contrast media is not possible due to the allergy, renal dysfunction, or bronchial asthma, unenhanced CT is acceptable.
*2 If the use of contrast media is not possible due to the allergy, renal dysfunction, or bronchial asthma, unenhanced MRI is permissible. If MRI is not possible due to a pacemaker or claustrophobia, evaluation by CT is permissible.
a) The number of metastases is three or less. Lymph node metastases count as one metastasis per lymph node and are included in the number of metastatic organs.
b) No local recurrence (*3), regardless of the number of metastases.
*3 This study defines local recurrence as recurrence at the resection margin, including the bronchial stump, the hilar and mediastinal lymph nodes on the ipsilateral side as the primary lesion, the hilar and mediastinal lymph nodes on the contralateral side, the intrapulmonary lymph nodes on the ipsilateral side, malignant pleural effusion on the ipsilateral side, and disseminations on the ipsilateral
c) If the number of metastasis is one, it should not be limited to one lung nodule.
d) Regardless of the number of metastases, the metastases are not limited to the brain only,
e) All of the following criteria are met for bone metastasis.
- Not metastasis to three consecutive vertebral bodies.
- Not vertebral metastasis (Bilsky grade 1b or higher) that shows progression into the spinal canal.
- Not long bone metastasis.
- Does not have severe pain that is poorly controlled by medication.
f) All of the following criterial are met for brain metastasis.
- The largest tumor diameter is 3cm or less and asymptomatic.
- If there are multiple brain metastases, the total of the the largest tumor diameter is 5 cm or less.
(6) All metastatic lesions can be treated by local therapies as determined by the participating institution's surgeon or radiotherapist.
(7) In non-squamous cell carcinoma, EGFR gene driver mutations (exon 19 deletion, L858R, G719X, L861Q, S7681, and these mutations with T190M mutation) and ALK immunostaining/ALK fusion genes are negative (EGFR gene teting and ALK immunostaining/ALK fusion gene are not mandatory in squamous cell carcinoma).
(8) ROS1 fusion gene, BRAF (V600E) gene mutation, MET exon 14 skipping mutation, RET fusion gene, and NTRK fusion gene are negative or unknown.
(9) The age on the primary registration is 18 or older.
(10) Performance status (PS) is 0 or 1 according to ECOG criteria (PS must always be recorded in the medical record).
(11) No history of systemic chemotherapy for metastasis lesions, excluding preoperative and postoperative adjuvant chemotherapy.
(12) The latest values within 14 days before the primary resistrartion meet all of the following.
a) Neutrophils>=1,500/mm3
b) Hemoglobine>=9.0 g/dL (no blood transfusion has been performed within 14 days before the blood collection used for the registration)
c) Platelet count>=100,000/mm3
d) Total bilirubin<=1.5 mg/dL
e) AST<=100 U/L(If there is liver metastasis, AST <= 200 U/L)
f) ALT<=100 U/L(If there is liver metastasis, ALT<= 200 U/L)
g) Serum creatinine<=1.5 mg/dL
h) SpO2>=92% under room air (SpO2 must always be recorded in the medical record)
(13) Written informed consent has been obtained from the patient to participate in the study.

Criteria for the secondary registration
(1) Primary registration was performed, and 4 courses (1 couse = 3 weeks) of induction therapy have been performed ( even if the administration on day 8 and day 15 or day 15 of the fourth course is skipped), or the induction therapy is terminated at the third courses due to adverse events).
(2) No apparent increase in size(*) in any of metastases or new distatnt metastasis are observed.
* An apparent increase is considered to be when the long diameter of any lesion is increased by more than 10% and more than 5 mm compared to the diameter before treatment. However, lymph nodes are evaluated by their short diameter.
(3) The secondary registration date is within 28 days (4 weeks) of the response evaluation of induction therapy (if there are multiple image modalityes used for the evaluation, the date of the latest examination is adopted).
(4) Within 64 days (9 weeks) to 182 days (26 weeks) after primary registration.
(5) No metastatic site larger than 3 cm in tumor diameter.
(6) If brain metastases are found at the time of primary registration, radical local therapy (stereotactic irradiation or stereotactic radiotherapy) has been performed.
(7) Al least one oligometastasis that canbe treated locally remains. However, brain lesions where radical local therapy has been performed are not included.
(8) All metastatic lesions can be treated by local therapies as determined by the participating institution's surgeon or radiotherapist.
(9) PS is 0 or 1 according to ECOG criteria (PS must always be recorded in the medical record).
(10) The latest values within 14 days before the secondary resistrartion meet all of the following.
a) Neutrophils>=1,500/mm3
b) Hemoglobine>=9.0g/dL(no blood transfusion has been performed within 14 days before the blood collection used for the registration)
c) Platelet count>=100,000/mm3
d) Total bilirubin<=1.5mg/dL
e) AST<=100U/L(If thereis liver metastasis, AST<=200U/L)
f) ALT<=100U/L(If thereis liver metastasis, ALT<=200U/L)
g) Serum creatinine <=1.5mg/dL
h) SpO2>=92% under room air (SpO2 must always be recorded in the medical record)

除外基準 / Exclude criteria

(1) Simultaneous or metachronous (within 2 years) double cancers, with the exception of intramucosal tumor curable with local therapy. However, even if the disease-free period is less than 2 years, the following are not considered to be active second primary cancers: prostate cancer in clinical stage I, laryngeal cancer in clinical stages 0 and I that have responded completely to radiation therapy, completely resected lung adenocarcinoma without vascular invasion Stage 0-IA2 (regardless of surgical method), cancers with a 5-year relative survival rate of 95% or more, such as cancers with the following pathological stages (cancers with a history of complete resection are not included in the category of active multiple cancers/multiple cancers).
(2) Active infection requiring systemic therapy.
(3) Fever over 38 degrees Celsius
(4) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
(5) Psychological disorder difficult to participate in this clinical study.
(6) Receiving a continuous systemic administration (oral or intravenous) of steroids exceeding 10 mg/day in predonisolone equivalents, or other immunosuppressive drugs.
(7) Uncontrollable diabetes mellitus.
(8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
(9) Have an uncontrolled valvular disease, dilated cardiomyopathy, hypertrophic cardiomyopathy.
(10) One or a combination of the following conditions diagnosed via chest CT scan: interstitial pneumonia, severe pulmonary fibrosis, or seveare emphysema.
(11) Positive HBs antigen and/or HCV antibody.

責任研究者

• 責任研究者 / Name of lead principal investigator: Shun-ichi Watanabe
• 部署名 / Division: National Cancer Center Hospital
• 住所 / Address: 5-1-1 Tsukiji, Chuo City, Tokyo, 104-0045 Japan Tokyo Japan 104-0045
• 電話 / Telephone: [phone]
• 実施責任組織 / Affiliation: 渡辺 俊一
• 実施責任組織 / Affiliation: National Cancer Center Hospital
• 研究費提供組織 / Funding Source: National Cancer Center Japan

試験問い合わせ窓口

• 住所 / Address: 5-1-1 Tsukiji, Chuo City, Tokyo, 104-0045 Japan Tokyo Japan 104-0045
• 電話 / Telephone: [phone]
• E-mail: [e-mail]
• 担当者 / Name of contact person: Masaya Yotsukura