Study of Cetuximab With Concomitant-boost Radiotherapy in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
2014年2月10日 更新者:Merck KGaA, Darmstadt, Germany
Open-label, Non-randomized, Non-controlled, Multicenter Phase II Study Investigating Cetuximab in Combination With Concomitant-boost Radiotherapy as First-line Treatment for Japanese Patients With Newly Diagnosed Locally Advanced SCCHN.
This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT) regimen (the study treatment) and its safety profile (i.e.
AEs: adverse events).
In addition, efficacy (i.e.
anti-tumor effect) of the study treatment is also evaluated.
調査の概要
研究の種類
介入
入学 (実際)
27
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Aichi、日本
- Research Site
-
Chiba、日本
- Research Site
-
Shizuoka、日本
- Research Site
-
Tokyo、日本
- Research Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- The patient has pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx, or larynx.
- The patient has been confirmed Epidermal Growth Factor Receptor expressing in tumor specimen by immunohistochemistry.
- The patient has stage III or IV disease (Unio Internationalis Contra Cancrum / International Union against Cancer Tumor-Lymph Nodes-Metastases classification) with an expected survival of ≥ 12 months.
- The patient has at least bi-dimensionally measurable disease.
- The patient is medically suitable to withstand a course of the definitive radiation therapy.
- The patient aged ≥ 20 years old at informed consent
- The patient's Karnofsky performance status is ≥ 60
- Hemoglobin ≥ 9g/dL
- Neutrophil ≥ 1500/mm^3
- Platelet ≥ 100,000/mm^3
- Total Bilirubin ≤ 1.5 mg/dL
- Aspartate Aminotransferase ≤ 2 x the upper limit of normal
- Alanine Aminotransferase ≤ 2 x the upper limit of normal
- Serum creatinine ≤ 1.5 mg/dL
- Serum calcium concentration: within normality
- The patient is eligible if disease free from a previously treated malignancy for greater than three years.
- The patient agrees to use effective contraception if procreative potential exists.
- The patient has given signed informed consent
- The patient who is a Japanese with Japanese citizenship
Exclusion Criteria:
- The patient has evidence of distant metastatic disease. The patient who has any metastatic disease documented by Magnetic Resonance Imaging for the head and neck, and Computed Tomography for the chest and abdomen should be excluded.
- The patient has squamous cell carcinoma arising in the nasopharynx or oral cavity.
- The patient has received prior systemic chemotherapy within the last three years.
- The patient has undergone previous surgery for the tumor under study other than biopsy.
- The patient has received prior radiation therapy to the head and neck.
- The patient's radiation therapy is considered to be a part of a postoperative regimen following primary surgical resection.
- The patient is pregnant or breast feeding.
- The patient has received prior Cetuximab or murine monoclonal antibody (including chimeric antibody) therapy or a history of severe hypersensitivity to any component of Cetuximab solution for Injection.
- The patient has a medical or psychological condition that would not permit the patient to complete the study or sign informed consent (including drug abuse).
- The patient has uncontrolled diabetes mellitus, malignant hypertension, or liver failure.
- The patient has or has suffered from a pulmonary fibrosis, acute pulmonary disorder, or interstitial pneumonia.
- The patient has an active infection (infection requiring intravenous anti-bacterial, anti-fungus, or anti-viral agent), or known and declared Human Immunodeficiency Virus infection.
- The patient has a clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
- The patient has a dental disease which requires incision and drainage.
- The patient has active multiple cancers (excluding skin cancer except for melanoma, and carcinoma in situ of the cervix or the digestive tract) in the last 3 years.
- The patient has been received some investigational medication within 30 days before study entry.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Cetuximab With Radiotherapy
|
Patients receive Cetuximab at an initial dose of 400 mg/m^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course.
Subjects will receive Cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn.
If RT is delayed, administration of Cetuximab every 7 days is continued.
If RT is discontinued for any reason, treatment with Cetuximab monotherapy every 7 days is continued.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Completion Rate
時間枠:time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks
|
Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population
|
time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Best Response Rate
時間枠:best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required
|
Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population
|
best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required
|
Safety - Number of Patients Experiencing Any Adverse Event
時間枠:time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
Please refer to Adverse Events section for further details
|
time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
Safety - Number of Patients Experiencing Any Grade 4 Adverse Event
時間枠:time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject's health and well-being, and the ability of the subject to function during the event.
|
time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction
時間枠:time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms.
Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
|
time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction
時間枠:time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms.
Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
|
time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター:Masataka Ota, MD、Merck Serono Co.,Ltd, an Affilate of Merck Serono, Darmstadt, Germany
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年3月1日
一次修了 (実際)
2010年6月1日
研究の完了 (実際)
2010年6月1日
試験登録日
最初に提出
2009年3月18日
QC基準を満たした最初の提出物
2009年3月18日
最初の投稿 (見積もり)
2009年3月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年3月12日
QC基準を満たした最後の更新が送信されました
2014年2月10日
最終確認日
2014年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- EMR 62241-053
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。