A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
研究概览
详细说明
研究类型
注册
阶段
- 阶段1
联系人和位置
学习地点
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Maryland
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Bethesda、Maryland、美国、20892
- National Cancer Institute (NCI)
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
No lymphomas or neuroendocrine tumors.
No peritoneal carcinomatosis.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: More than 4 weeks since immunotherapy.
Chemotherapy:
No prior chemotherapy for newly diagnosed disease.
More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
Endocrine Therapy: More than 4 weeks since hormonal therapy.
Radiotherapy:
No prior radiotherapy for newly diagnosed disease.
No prior abdominal or pelvic radiotherapy.
More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
Surgery:
Prior resection allowed.
Biliary decompression or gastric bypass allowed.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Hematopoietic:
ANC greater than 2,000/mm(3).
Platelets greater than 100,000/mm(3).
Hepatic: AST/ALT no greater than 2.5 times normal.
Renal:
Creatinine less than 1.5 mg/dL.
Creatinine clearance at least 60 mL/min,
Cardiovascular:
No myocardial infarction within 6 months.
No unstable angina.
No congestive heart failure (NYHA class III/IV).
OTHER:
HIV seronegative.
No medical or psychiatric contraindication to protocol therapy.
No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
No pregnant or nursing women.
Adequate contraception required of fertile patients.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
出版物和有用的链接
一般刊物
- Morohoshi T, Held G, Kloppel G. Exocrine pancreatic tumours and their histological classification. A study based on 167 autopsy and 97 surgical cases. Histopathology. 1983 Sep;7(5):645-61. doi: 10.1111/j.1365-2559.1983.tb02277.x.
- Rosenberg JM, Welch JP, Macaulay WP. Cancer of the head of the pancreas: an institutional review with emphasis on surgical therapy. J Surg Oncol. 1985 Mar;28(3):217-21. doi: 10.1002/jso.2930280315.
研究记录日期
研究主要日期
学习开始
研究完成
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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吉西他滨的临床试验
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Fondazione Policlinico Universitario Agostino Gemelli...招聘中