Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery (CKNO-RERT)
Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.
Secondary
- Determine the incidence of cutaneous toxicity.
- Assess the care and development of skin reactions.
- Determine the quality of life of patients treated with this drug.
- Determine tumor response at 2 months.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic radiotherapy 3 times weekly during weeks 2 and 3.
After completion of study therapy, patients are followed at 2 months and then every 3 months for 2 years.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
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-
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Lille、フランス、59020
- Centre Oscar Lambret
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck
- Unresectable disease
- Recurrent disease
- No metastatic disease
Disease in previously irradiated area must be proven by biopsy or imaging
- At least 3 months between prior radiotherapy and diagnosis of recurrent disease
- Surgery or brachytherapy must be possible
- Measurable or evaluable disease by RECIST criteria
- No available curative therapy
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Not pregnant or nursing
- No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible
- No other malignant disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent participation in another clinical study of an experimental drug
研究計画
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：非ランダム化
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 |
|---|
|
Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Eric Lartigau, MD, PhD、Centre Oscar Lambret
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CKNO-RERT-0705
- 2007-A00503-50 (その他の識別子：AFSSAPS)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。