Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.
研究概览
详细说明
OBJECTIVES:
- Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Saskatchewan
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Regina、Saskatchewan、加拿大、S4T 7T1
- Allan Blair Cancer Centre
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Arizona
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Scottsdale、Arizona、美国、85259-5404
- CCOP - Scottsdale Oncology Program
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District of Columbia
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Washington、District of Columbia、美国、20060
- MBCCOP - Howard University Cancer Center
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Illinois
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Peoria、Illinois、美国、61636
- Methodist Medical Center of Illinois
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Peoria、Illinois、美国、61602
- CCOP - Illinois Oncology Research Association
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Urbana、Illinois、美国、61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids、Iowa、美国、52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines、Iowa、美国、50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City、Iowa、美国、51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita、Kansas、美国、67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans、Louisiana、美国、70121
- CCOP - Ochsner
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Michigan
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Ann Arbor、Michigan、美国、48106
- CCOP - Michigan Cancer Research Consortium
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Minnesota
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Duluth、Minnesota、美国、55805
- CCOP - Duluth
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Rochester、Minnesota、美国、55905-0001
- Mayo Clinic Cancer Center
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Saint Cloud、Minnesota、美国、56303
- CentraCare Health Plaza
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Saint Louis Park、Minnesota、美国、55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha、Nebraska、美国、68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck、North Dakota、美国、58501-5505
- Medcenter One Health System
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Fargo、North Dakota、美国、58122
- CCOP - Merit Care Hospital
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Grand Forks、North Dakota、美国、58201
- Altru Cancer Center
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Ohio
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Toledo、Ohio、美国、43623-3456
- CCOP - Toledo Community Hospital
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Pennsylvania
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Danville、Pennsylvania、美国、17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Pittsburgh、Pennsylvania、美国、15212-4772
- Allegheny General Hospital
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South Dakota
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Rapid City、South Dakota、美国、57709
- Rapid City Regional Hospital
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Sioux Falls、South Dakota、美国、57104
- CCOP - Sioux Community Cancer Consortium
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Wisconsin
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Green Bay、Wisconsin、美国、54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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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:
- Histologically confirmed unresectable adenocarcinoma of the pancreas
- No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
Prior subtotal resection or gross residual disease
- No microscopic residual disease only
- No metastatic disease outside of planned study radiotherapy field
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to maintain adequate oral nutrition
- No significant infection
- No other medical condition that would preclude study
- No other malignancy within the past 5 years except non-melanoma skin cancer
- No significant nausea or vomiting
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior or concurrent biologic therapy
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy that would overlap planned study radiotherapy fields
Surgery:
- See Disease Characteristics
- At least 21 days since prior laparotomy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：radiotherapy + gemcitabine + cisplatin
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
总生存期
大体时间：12个月
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12个月
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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quality of life
大体时间：Up to 3 years
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Up to 3 years
|
合作者和调查者
出版物和有用的链接
一般刊物
- Haddock MG, Swaminathan R, Foster NR, Hauge MD, Martenson JA, Camoriano JK, Stella PJ, Tenglin RC, Schaefer PL, Moore DF Jr, Alberts SR. Gemcitabine, cisplatin, and radiotherapy for patients with locally advanced pancreatic adenocarcinoma: results of the North Central Cancer Treatment Group Phase II Study N9942. J Clin Oncol. 2007 Jun 20;25(18):2567-72. doi: 10.1200/JCO.2006.10.2111.
- Haddock MG, Swaminathan R, Alberts SR, et al.: Gemcitabine (Gem), cisplatin (Cis) and radiation therapy (RT) for patients with locally advanced pancreatic adenocarcinoma (ACA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] J Clin Oncol 22 (Suppl 14): A-4121, 343s, 2004.
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
与本研究相关的术语
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放射治疗的临床试验
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Abbott Medical Devices完全的
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的