NCT00079365Unknown不适用
A Randomized Trial Comparing 5-Fluorouracil, External Beam Radiation, and Gemcitabine With or Without P Radiopharmaceutical Therapy As A First Line Therapy in Patients With Locally/Regionally Advanced Non-Resectable Adenocarcinoma of the Pancreas
适应症
相关药物
试验速览
- 阶段
- 不适用
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Fluorouracil may make the tumor cells more sensitive to radiation therapy. Brachytherapy uses radioactive material, such as phosphorus P32, placed directly into or near a tumor to kill tumor cells. Combining chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor cells.
PURPOSE: This randomized clinical trial is studying fluorouracil, gemcitabine, external-beam radiation therapy, and brachytherapy using phosphorus P32 to see how well they work compared to fluorouracil, gemcitabine, and external-beam radiation therapy in treating patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas (pancreatic cancer).
详细描述
OBJECTIVES:
Primary
- Compare the survival of patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas treated with fluorouracil, external beam radiotherapy, and gemcitabine with vs without brachytherapy with phosphorus P32 suspension.
Secondary
- Compare time to disease progression, tumor response rate, and physical performance in patients treated with these regimens.
- Compare the safety and tolerability of these regimens in this patient population.
- Compare duration of response and time to treatment failure in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed pancreatic adenocarcinoma
- •Locally or regionally advanced disease
- •Unresectable disease defined by the following:
- •Invasion into a major vascular structure determined preoperatively by a CT scan, angiogram, or CT portogram or intraoperatively by surgeon
- •Severe comorbidities precluding operation, such as congestive heart failure, coronary artery disease, or chronic obstructive pulmonary disease
- •Bidimensionally measurable disease by CT scan
- •No recurrent disease
- •No previously resected pancreatic cancer
- •No tumors of the pancreas not ductal in origin (e.g., islet cell tumors, lymphoma, or sarcoma)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count: ≥ 1,500/mm^3
- •Platelet count ≥ 50,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin < 2 times upper limit of normal (ULN)
- •AST and ALT < 5 times ULN
- •Alkaline phosphatase < 5 times ULN
- •Albumin ≥ 2.5 mg/dL
- •Creatinine ≤ 1.5 mg/dL
- •Cardiovascular
- •See Disease Characteristics
- •See Disease Characteristics
- •No other malignancy within the past 5 years except curatively resected basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or early stage prostate cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy for pancreatic adenocarcinoma
- •See Disease Characteristics
- •No prior chromic phosphate P32 suspension (Phosphocol®)
- •At least 4 weeks since prior cytotoxic therapy for pancreatic adenocarcinoma
- •At least 4 weeks since prior investigational anti-tumoral agents
- •No other concurrent investigational agents
- •No other concurrent anticancer agents
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By SurgeryPancreatic CancerNCT00303758Federation Francophone de Cancerologie Digestive202
已完成
3 期
Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the ColonColorectal CancerNCT00085163European Organisation for Research and Treatment of Cancer - EORTC
已完成
3 期
Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes' B Or Dukes' C Colon CancerColorectal CancerNCT00425152NSABP Foundation Inc2,151
已完成
2 期
Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic CancerPancreatic CancerNCT00026130Alliance for Clinical Trials in Oncology81
终止
3 期
Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal AdenocarcinomaStage II/IIIT3 or T4 (Only Anal Extension) Rectal CancerN0-2M0Rectal CancerNCT00207831Institut Cancerologie de l'Ouest219