Prospective study of patients treated with pegylated interferon-alpha 2b (PegIntron) for metastasizing ileal/coecal carcinoids - NA

ppsala University Hospital, Dept. of Medical Sciences0 个研究点目标入组 90 人开始时间: 2008年9月2日最近更新: 2012年6月12日

适应症

试验速览

暂无简介。

•Patients suffering from metstasizing, histopathologically verified (chromogranin A and serotonin immunohistochemistry must be positive), highly differentiated NE carcinomas of the jejunum/ileum/valvula Bauhini and the adjacent parts of coecum/colon ascendens. Patients with NE carcinomas of the duodenum, the appendix (including also goblet-cell carcinoids) are not included, neither those with poorly differentiated NE carcinomas (proliferation index higher than 15 %)
•Measurable disease as diagnosed by means of CT or MRI according to the RECIST criteria
•U-5-HIAA > 2 x upper normal limit and/or P-Chromogranin A > 2 x upper normal limit
•Age >18 years.
•Life expectancy of more than 12 months
•Patients must be willing to give written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Previous or present interferon treatment
•Previous radioactive tumour-targeting treatment
•Other active or previous neoplasms within 5 years (except non-melanoma skin cancer or in situ cervical cancer)
•Liver embolization or radiofrequency ablation within 3 months prior to screening
•Patients who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease
•Contraindications to the investigational product, e.g. known or suspected hypersensitivity

发起方

ppsala University Hospital, Dept. of Medical Sciences