Phase II study to evaluate the efficacy of fractionated stereotactic body radiotherapy and gemcitabine/erlotinib chemotherapy for unresectable locally advanced pancreatic cancer

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 34 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Histologically or cytologically confirmed adenocarcinoma of the pancreas.
•2. Unresectable disease. Tumors were considered to be unresectable if they demonstrated any of the following finding: (a) superior mesenteric artery or celiac encasement greater than 180 degrees, (b) unreconstructible superior mesenteric vein/portal occlusion or (c) aortic invasion;
•3. An age = 18 years.
•4. An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
•5. Adequate bone marrow functional reserve (leukocytes >3,000/µL, an absolute neutrophil count >1,500/µL and a platelet count >100,000/µL).
•6. Adequate hepatic and renal functional reserve (total bilirubin <1.5 times the institutional limits, aspartate aminotransferase/alanine aminotransferase <2.5 times the institutional limits and creatinine within the institutional limits).
•7. Signed informed consent must be obtained prior to any of the study's specific procedures.

•1. Distant metastases or resectable disease.
•2. Gastric/duodenal wall invasion or regional lymph node metastases.
•3. Patients who have had prior radiotherapy to the upper abdomen.
•4. Pregnant and breastfeeding women or women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy.
•5. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with the study requirements.
•6. Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.
•7. Patients who had uncontrolled gastric or duodenal ulcer.

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