Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.
研究概览
详细说明
OBJECTIVES:
- Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer.
- Test the value of adding cisplatin to fluorouracil in extending survival in these patients.
OUTLINE: This is a multicenter, randomized study.
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment.
Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant.
Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs.
PROJECTED ACCRUAL: 200 patients will be accrued.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Holon、以色列、58100
- Wolfson medical center
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Chieti、意大利、66100
- Universita G.D'Annunzio Di Chieti
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Haine Saint Paul、比利时、7100
- Hôpital de Jolimont
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Liege、比利时、B 4000
- Les Cliniques Saint-Joseph ASBL
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Bayonne、法国、64109
- Centre Hospitalier de la Côte Basque
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Clermont-Ferrand、法国、63011
- Centre Jean Perrin
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Dijon、法国、21079
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
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Levallois-Perret、法国、92300
- Hopital Perpetuel Secours
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Limoges、法国、87042
- Centre Hospital Regional Universitaire de Limoges
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Metz、法国、55038
- Hopital Notre-Dame de Bon Secours
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Montlucon、法国、03109
- Centre Hospitalier de Montlucon
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Neuilly sur Seine、法国、92200
- Clinique Hartmann
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Paris、法国、75674
- Hôpital Cochin
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Paris、法国、75475
- Hopital Saint-Louis
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Saint Cloud、法国、92211
- Centre René Huguenin
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Saint Etienne、法国、42055
- Hopital Bellevue
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Strasbourg、法国、67010
- Clinique de l'Orangerie
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Villejuif、法国、94804
- Hopital Paul Brousse
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Amadora、葡萄牙、P-2700
- Hospital Fernando Fonseca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
- Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor
- Locally advanced and/or metastatic pancreatic cancer
- No measurable or evaluable target lesion is required
- No brain metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 40%-100%
Hematopoietic:
- WBC at least 3,000/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 3 times normal
Renal:
- Creatinine no greater than 1.24 mg/dL OR
- Creatinine clearance at least 80 mL/min
Cardiovascular:
- No overt cardiac disease
Other:
- No peripheral neuropathy
- No uncontrolled infectious or chronic disease
- No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunologic therapy
Chemotherapy:
- No prior chemotherapy allowed
Endocrine therapy:
- No concurrent hormonal therapy
- At least 2 weeks since corticoid treatment
Radiotherapy:
- No prior radiotherapy allowed except as an analgesic treatment on metastasis
Surgery:
- Not specified
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
合作者和调查者
调查人员
- 学习椅:Francis Levi, MD, PhD、Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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