Randomized Amifostine For SCCHN
Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
調査の概要
詳細な説明
Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.
The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Maine
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Sanford、Maine、アメリカ、04703
- Goodall Hospital
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center
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Boston、Massachusetts、アメリカ、02115
- Dana-Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Concord、Massachusetts、アメリカ、01742
- Bethke Cancer Center at Emerson Hospital
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Danvers、Massachusetts、アメリカ、01923
- Mass General/North Shore Cancer Center
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Fall River、Massachusetts、アメリカ、02721
- Saint Anne's Hospital - Fall River
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Lowell、Massachusetts、アメリカ、01854
- Lowell General Hospital
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New Hampshire
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Dover、New Hampshire、アメリカ、03820
- Wentworth Douglass Hospital
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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
受講資格のある性別
説明
Inclusion Criteria
- Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.
- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.
- Stage 2, 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound or CT (in case of liver function test abnormalities); bone scan in case of local symptoms.
- At least one uni- or bidimensionally measurable lesion at the start of all therapy (induction therapy ag well as chemoradiation).
- No previous head and neck radiotherapy and no previous curative surgery for SCCHN (other than biopsy) are allowed at time of study entry.
- Age ≥ 18 years.
- WHO performance status of 0 or 1 (section 13, Appendix I)
- No active alcohol addiction (as assessed by medical caregiver).
- Life expectancy ≥ 12 weeks.
- Signed informed consent prior to beginning protocol specific procedures.
Adequate bone marrow, hepatic and renal functions as evidenced by the following:
Hematology:
- neutrophil count ≥ 2.0 x 10 9/1.
- platelet count ≥ 100 x 10 9/1.
- hemoglobin ≥ 10 g/dl.
Hepatic function:
- total bilinthin WNL.
- ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x 1JLN.
- alkaline phosphatase ≤ 5 x ULN.
- patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5
- x ULN are not eligible for the study.
Renal function: the creatinine clearance ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows:
- Weight(kg) x (140 - age)/K x serum creatinine
serum creatinine in mg/dL
- K: 72 in man
- K: 85 in woman
serum creatinine in µmon/L
- K: 0.814 in man
- K: 0.96 in woman
- Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centers
- Previous chemotherapy is permitted, provided that it is in induction form before starting radiation therapy and that it is being used to treat head and neck cancers.
Exclusion Criteria:
- Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
- Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.
- Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.
Other serious illnesses or medical conditions including but not limited to:
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or seizures.
- Active uncontrolled infection.
- Active peptic ulcer.
- Hypercalcemia.
- Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
- Patients requiring intravenous alimentation.
- Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry (unless purposeful)
- Concurrent treatment with any other anticancer therapy.
- Participation in an investigational trial within 30 days of study entry.
- Previous treatment with any biologic therapy is not permitted.
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:ランダム化
- 介入モデル:並列代入
- 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 |
---|---|
アクティブコンパレータ:Arm A Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;
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与えられた IV
他の名前:
与えられた IV
他の名前:
皮下投与
他の名前:
Given once daily for 4 weeks and then twice daily for 2 weeks.
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実験的:Arm B No-Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN - 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). |
与えられた IV
他の名前:
与えられた IV
他の名前:
Given once daily for 4 weeks and then twice daily for 2 weeks.
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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 |
時間枠 |
---|---|
Rate of local/regional control (LRC) 1 year after beginning treatment
時間枠:One year after beginning of treatment
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One year after beginning of treatment
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Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months
時間枠:3, 6 Months
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3, 6 Months
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Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
時間枠:End of Radiotherapy
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End of Radiotherapy
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Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment
時間枠:8,12, 24 and 52 weeks
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8,12, 24 and 52 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment
時間枠:8, 12, 24, and 52 weeks
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8, 12, 24, and 52 weeks
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Proportion of patients with PEG dependency
時間枠:3, 6, and 12 months after completion of study treatment
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3, 6, and 12 months after completion of study treatment
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Time to disease progression
時間枠:baseline to disease progression
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Kaplan and Meier
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baseline to disease progression
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Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey
時間枠:baseline, 8, 12, 24, and 52 weeks after completion of study treatment
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baseline, 8, 12, 24, and 52 weeks after completion of study treatment
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LRC and overall survival at 2 years after completion of study treatment
時間枠:2 Years after completion of study treatment
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2 Years after completion of study treatment
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Swallowing function
時間枠:2 years Post treatment
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2 years Post treatment
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協力者と研究者
捜査官
- 主任研究者:Robert I. Haddad, MD、Dana-Farber Cancer Institute
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
- 原発不明の未治療の転移性頸部扁平上皮がん
- 潜在的な原発性扁平上皮癌を伴う転移性扁平上皮頸部癌
- 唇および口腔のIII期扁平上皮癌
- 唇および口腔のステージ IV 扁平上皮癌
- III期中咽頭扁平上皮がん
- IV期の中咽頭扁平上皮癌
- III期の下咽頭扁平上皮癌
- IV期の下咽頭扁平上皮癌
- 喉頭のIII期扁平上皮癌
- 喉頭のステージ IV 扁平上皮癌
- 副鼻腔および鼻腔のIII期扁平上皮がん
- 副鼻腔および鼻腔のIV期扁平上皮がん
- 放射線毒性
- 粘膜炎
- 唇および口腔のII期扁平上皮癌
- 副鼻腔および鼻腔のII期扁平上皮がん
- II期下咽頭扁平上皮癌
- 喉頭のII期扁平上皮癌
- 中咽頭のII期扁平上皮癌
- 口腔乾燥症
- 化学療法剤の毒性
追加の関連 MeSH 用語
その他の研究ID番号
- 03018
- P30CA006516 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。
カルボプラチンの臨床試験
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Virginia Commonwealth UniversityNational Cancer Institute (NCI)引きこもったステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 扁平上皮肺がん | 肺の腺癌 | 大細胞肺がん | ステージ IIA 非小細胞肺がん | ステージ IIB 非小細胞肺がん
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Children's Oncology GroupNational Cancer Institute (NCI)完了脳腫瘍 | 中枢神経系腫瘍アメリカ, カナダ, オーストラリア, スイス, オランダ, ニュージーランド