Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.
Secondary
- Determine the tolerability of this regimen, in both the short- and long-term, in these patients.
- Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefits of this regimen in these patients.
- Determine locoregional and metastatic progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
- Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy.
- Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
研究の種類
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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Avignon、フランス、84082
- Institut Sainte Catherine
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Bordeaux、フランス、33075
- Hopital Saint Andre
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Bordeaux、フランス、F-33000
- Clinique Tivoli
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Dijon、フランス、21000
- Hopital Drevon
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Grenoble、フランス、F-38043
- CHU de Grenoble - Hopital de la Tronche
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La Rochelle、フランス、17000
- Hopital Saint - Louis
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Le Mans、フランス、F-72000
- Clinique Victor Hugo
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Lyon、フランス、69008
- Clinique Saint Jean
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Marseille、フランス、13009
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
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Paris、フランス、75970
- Hôpital Tenon
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Paris、フランス、75571
- Hopital Saint Antoine
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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
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
- Locally advanced, nonresectable disease
- Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery
- No visceral or peritoneal metastases
- No adenocarcinoma of the bile ducts or the ampulla of Vater
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Stable or controlled pain with analgesics
- Not pregnant or nursing
- Neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times normal OR < 3 mg/dL
- Creatinine clearance ≥ 40 mL/min
- Bilirubin ≤ 1.5 times normal
- Alkaline phosphatase < 5 times normal
- No medical condition that would preclude study treatment
- No active infection
- Negative pregnancy test
- No serious cardiac or respiratory disease
- No uncontrolled or persistent hypercalcemia
- No pre-existing neuropathy
- No biliary or gastro-duodenal obstruction
- No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder
- No familial, social, geographical, or psychological condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)
- At least 2 months since prior radiotherapy
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
- マスキング:なし(オープンラベル)
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 |
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無増悪生存
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二次結果の測定
結果測定 |
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回答率
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全生存
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生活の質
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忍容性
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無再発生存
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臨床上の利点
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Locoregional and metastatic progression-free survival
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協力者と研究者
捜査官
- スタディチェア:Laurence Moureau-Zabotto, MD、Institut Paoli-Calmettes
出版物と役立つリンク
一般刊行物
- Moureau-Zabotto L, Phelip JM, Afchain P, Mineur L, Andre T, Vendrely V, Lledo G, Dupuis O, Huguet F, Touboul E, Balosso J, Louvet C. Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: a Groupe Coordinateur Multidisciplinaire en Oncologie phase II study. J Clin Oncol. 2008 Mar 1;26(7):1080-5. doi: 10.1200/JCO.2007.12.8223.
- Moureau-Zabotto L, Phélip J, Afchain P, et al.: Concomitant administration of weekly oxaliplatin, 5FU continuous infusion and radiotherapy in locally advanced pancreatic cancer (LAPC): a Gercor phase II study. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1077, S173-4, 2006.
研究記録日
主要日程の研究
研究開始
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
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。
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