A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma

Masonic Cancer Center, University of Minnesota1 个研究点分布在 1 个国家目标入组 23 人开始时间: 2005年1月最近更新: 2017年12月28日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Masonic Cancer Center, University of Minnesota
入组人数: 23
试验地点: 1
主要终点: Number of Patients in Whom Tumor Was Resectable

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy and radiation therapy together with interferon alfa before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy and radiation therapy together with interferon alfa works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

详细描述

OBJECTIVES:

Primary

Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting patients with locally advanced unresectable adenocarcinoma of the pancreas to resectability.

Secondary

Determine the rate and severity of early and late toxic effects of these regimens in these patients.
Improve surgical morbidity profile and overall survival of patients who undergo surgical resection.
Determine overall and progression-free survival of patients treated with this regimen.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Patient must have newly diagnosed computated tomography (CT) and endoscopic ultrasound(EUS) stage Tx-4, N0-1, M0 adenocarcinoma of pancreas according to the American Joint Committee on Cancer (AJCC) staging system. The following cell types will NOT be eligible: adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma
•Treatment must begin within 60 days of diagnosis
•Must have locally advanced inoperable pancreatic cancer with no metastatic spread as determined by a baseline diagnostic CT scan of the chest, endoscopic ultrasound and CT scan with intravenous (IV) contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration.
•No prior systemic chemotherapy or radiation therapy for pancreatic cancer
•Documented Eastern Cooperative Oncology Group (ECOG/Zubrod) performance status 0-1 within 14 days prior to registration
•Adequate hematologic, renal and hepatic function as defined by the following laboratory values (completed within 14 days prior to registration)
•white blood cell (WBC) > 3,000 mm3
•absolute neutrophil count (ANC) > 1,500 mm3
•platelet count ≥ 100,000 mm3
•hemoglobin > 9.5 g/dl
•serum creatinine < 1.5 times institutional upper limit of normal (ULN)
•total bilirubin ≤ 3 mg/dl
•AST (SGOT) < 4.0 times institutional ULN
•ALT (SGPT) < 4.0 times institutional ULN
•alkaline phosphatase < 2.0 times institutional ULN
•Age ≥ 18 years
•Life expectancy ≥ 12 weeks
•Patient (male or female) of reproductive potential are required to use a medically acceptable contraception during treatment and for 3 months after the last dose of chemotherapy.
•Not pregnant or breastfeeding since the drugs used in this study are Pregnancy Category D: Clear evidence of risk in pregnancy. A negative pregnancy test is required within 7 days of registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration)
•If patient has a previous diagnosis of cancer, all of the following criteria must be met and documented in the patient's medical record:
•Patient has undergone potentially curative therapy for all prior malignancies.
•No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, carcinoma in situ of the breast, or nonmelanoma skin cancer.
•No evidence of recurrence of any prior malignancy.
•Patient who is receiving chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality are not eligible.
•Not requiring one or more of the contraindicated medications
•Patient must be able to understand the potential risks and benefits associated with this study. Patient able to give informed consent and would likely to comply with the study parameters.

排除标准

未提供