試験ID jRCTs031250688
最終情報更新日：2026年5月26日
JCOG2405: 高用量シスプラチン併用化学放射線療法不耐の高齢者頭頸部扁平上皮癌に対するWeekly CDDP併用化学放射線療法の意義を検証するランダム化比較第III相試験
基本情報
| 試験ID | jRCTs031250688 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | JCOG2405: 高用量シスプラチン併用化学放射線療法不耐の高齢者頭頸部扁平上皮癌に対するWeekly CDDP併用化学放射線療法の意義を検証するランダム化比較第III相試験 | JCOG2405: A randomized phase III trial of WEEKLY cisplatin chemoradiotherapy versus radiotherapy in ELDERly head and neck squamous cell carcinoma patients unfit for high-dose cisplatin |
| 平易な研究名称 / Public Title（Acronym） | JCOG2405: A phase III trial of WEEKLY cisplatin chemoradiotherapy in ELDERly patients with head and neck cancer | |
| 試験進捗状況/Recruitment status | Recruiting | |
| 登録日時 | 2026年1月28日 | |
| 最終情報更新日 | 2026年5月26日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | |
|---|---|---|
| 実施都道府県 | 東京都 | |
| 目標症例数/Target sample size | 250 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 頭頸部扁平上皮癌 | head and neck squamous cell carcinoma |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | A群：RT単独 ＊RT：1回2 Gy、1日1回、週5日、計35回、総線量70 Gy。IMRTのSIB 56法にて実施する。 B群：Weekly CDDP併用CRT ＊CDDP40 mg/m2：放射線治療開始と同時に1週1コースとして7コース行う（day 1、day 8、day 15、day 22、day 29、day 36、day 43）。 ＊RT：1回2 Gy、1日1回、週5日、計35回、総線量70 Gy。IMRTのSIB 56法にて実施する。 | |
| 主要評価項目 / Primary outcomes | 全生存期間 | Overall survival |
| 副次評価項目 / Secondary outcomes | 無増悪生存期間、治療成功期間1、治療成功期間2、無局所領域増悪生存期間、完全奏効割合、局所領域増悪累積発生割合、遠隔転移累積発生割合、原病死累積発生割合、他因死累積発生割合、有害事象発生割合、重篤な有害事象発生割合、Dose intensity（シスプラチン）、治療完遂割合、QOLスコア、IADL非悪化割合 | Progression-free survival, time-to-treatment-failure 1, time-to-treatment-failure 2, loco-regional progression-free survival, complete response proportion, cumulative incidence of loco-regional progression, cumulative incidence of distant metastasis, cumulative incidence of disease-specific death, cumulative incidence of death from other causes, proportion of adverse events, proportion of serious adverse events, dose intensity of cisplatin, proportion of protocol treatment completion, QOL survey, proportion of patients without IADL deterioration |
適格性
| 年齢（下限）/ Age minimum | 70歳以上 | >= 70age old |
|---|---|---|
| 年齢（上限）/ Age maximum | Not applicable | |
| 性別 / Gender | 男女両方 | Both |
| 選択基準 / Include criteria | (1) Primary lesion exists in the oropharynx, hypopharynx, or larynx. (2) Histologically proven squamous cell carcinoma from primary leision biopsy. In case of oropharyngeal cancer, p16 is negative or positive by immunohistochemical staining. (3) Diagnosed as stage III-IVB for p16-negative oropharyngeal, hypopharyngeal, or laryngeal cancer, and as stage II (T1-3N2M0) or stage III for p16-positive oropharyngeal cancer (UICC-TNM 8th edition), by the following examinations. (i) Head and neck contrast-enhanced CT or MRI (ii) Thoracoabdominal CT (4) Aged 70 years and older. (5) ECOG Performance status (PS) 0-2. (6) For age, PS, renal function, and comorbidities, any of the following (i)-(vi) are met. * Comorbidity A: cardiovascular disease, diabetes mellitus, liver cirrhosis, cerebrovascular disease, chronic pulmonary disease, hearing impaired. (i) All of the following (a)-(d) are met. (a) age 70-74 years, (b) PS 0-1, (c) eGFR >= 60 mL/min/1.73 m2, (d) at least one comorbidity A present (ii) All of the following (a)-(c) are met. (a) age 70-74 years, (b) PS 0-1, (c) eGFR 50-<60 mL/min/1.73 m2 (iii) All of the following (a)-(d) are met. (a) age 70-74 years, (b) PS 2, (c) eGFR >= 50 mL/min/1.73 m2, (d) no comorbidity A (iv) All of the following (a)-(d) are met. (a) age >= 75 years, (b) PS 0, (c) eGFR >= 80 mL/min/1.73 m2, (d) at least one comorbidity A present (v) All of the following (a)-(c) are met. (a) age >= 75 years, (b) PS 0, (c) eGFR 50-<80 mL/min/1.73 m2 (vi) All of the following (a)-(c) are met. (a) age >= 75 years, (b) PS 1, (c) eGFR >= 50 mL/min/1.73 m2 (7) Presence of measurable lesions is not mandatory. (8) All of the following criteria (i)-(iv) are met. (i) No history of treatment with CDDP for any cancer. (ii) No history of radiation therapy for the brain and head and neck. (iii) No history of surgery for cancers with a primary site in the oropharynx, hypopharynx, or larynx. (iv) No history of neck lymph node dissection for malignant tumors. (9) Any of the following criteria are met. (i) Judged that technically and functionally radical surgical resection is impossible by consulting with head and neck surgeon or otolaryngologist. (ii) Patients do not have a preference to receive a surgical resection, even though the surgeon judged surgical resection is possible. (10) No dementia, or dementia with family support to continue protocol treatment or examinations. (11) All of the following laboratory values are met. (i) Neutrophil count >= 1,500 /mm3 (ii) Hemoglobin >= 9.0 g/dl (iii) Platelet count >= 100,000 /mm3 (iv) T-bil <=2.0 mg/dL (v) AST <= 100 U/L (vi) ALT <= 100 U/L (12) Renal function: eGFR >= 50 mL/min/1.73 m2. (13) Written informed consent. | |
| 除外基準 / Exclude criteria | (1) Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy. (2) Active infection requiring systemic therapy. (3) Fever over 38 degrees Celsius. (4) Psychological disorder difficult to participate in this clinical study. (5) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (6) Uncontrolled arterial hypertension. (7) History of unstable angina pectoris within three weeks or myocardial infarction within twelve months before registration. (8) NYHA functional class II or higher, or EF < 50%. (9) Diabetes mellitus with HbA1c >= 8.0%. (10) Clinically diagnosed liver cirrhosis classified as Child-Pugh class B or C. (11) History of cerebrovascular disease within the past 12 months, or with residual deficits impairing activities of daily living or social functioning if occurred earlier. (12) Chronic pulmonary disease (interstitial pneumonia, pulmonary fibrosis, or severe emphysema, alone or in combination) with COPD classified as stage III or higher. (13) Hearing impaired of Grade >= 3, as defined by CTCAE v5.0 (Adults not enrolled on a Monitoring Program). (14) Positive for HBs antigen or HCV antibody. (15) Positive for HIV antibody. (16) Judged that smoking cessation and abstinence are impossible during protocol treatment. |
責任研究者
| 責任研究者 / Name of lead principal investigator | Yukihide KANEMITSU | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | ||
| 住所 / Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN Tokyo Japan 104-0045 | |
| 電話 / Telephone | +81-3-3542-2511 | |
| 実施責任組織 / Affiliation | 金光 幸秀 | National Cancer Center Hospital |
| 研究費提供組織 / Funding Source | ||
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN Tokyo Japan 104-0045 | |
|---|---|---|
| 電話 / Telephone | +81-3-3542-2511 | |
| ホームページURL | ||
| webmaster01@ml.jcog.jp | ||
| 担当者 / Name of contact person | Hiroshi KATAYAMA |
倫理審査委員会
| 認定臨床研究審査委員会又は倫理審査委員会の名称 | ||
|---|---|---|
| 上記委員会の認定番号 | 住所 / Address | |
| 電話番号 | ||
| 審査受付番号 | ||
| 当該臨床研究に対する審査結果 | ||
| 認定臨床研究審査委員会の承認日 | ||
変更・中止の場合
| 中止届出日 | ||
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| 中止年月日 | ||
| 中止の理由 | ||
終了の場合
| 終了届出日 | ||
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| 観察期間終了日 | ||
| 実施症例数 | ||
| 参加者の流れ（Participant flow） | ||
| 研究対象者の背景情報 | ||
| 疾病等の発生状況のまとめ | ||
| 主要評価項目及び副次評価項目のデータ解析及び結果 | ||
| 公開予定日 | ||
| 要約 | ||
| 研究実施計画書のURL | ||
| 結果に関する最初の出版物での発表日 | ||
| 結果と出版物に関するURL | ||
IPD data sharing
| 個々の研究対象者単位のデータ（IPD）を共有する計画 | ||
|---|---|---|
| 計画の説明 | ||