Efficacy and Safety of Mistletoe Extract in the Palliative Therapy of Patients Suffering from Pancreatic Cancer (PALM-Pan)

Verein für Krebsforschung0 个研究点目标入组 290 人开始时间: 2014年12月16日最近更新: 2020年6月22日

适应症

试验速览

暂无简介。

•1. Patients with diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas (UICC stadium III or IV), histologically confirmed if easily accessible
•2. Age between 18 and 90 years at study enrolment, legal competence
•3. Voluntarily given written informed consent in advance of any study-specific procedure
•4. No pre-treatment with mistletoe extracts
•5. No option for surgical resection or radiation in curative intent at the time of inclusion
•6. Adequate negative pregnancy test and adequate contraception for women of child-bearing age
•7. Scheduled Gemcitabine mono- or Gemcitabine-based combination chemotherapy starting within the next 4 weeks but only after baseline visit
•8. Adequate bone marrow function, assessed by laboratory values (existing results not older than 7 days may be used):
•8.1 Leucocyte count = 3000 / mm3
•8.2 Neutrophil count = 1500 / mm3
•8.3 Platelet count = 100.000 / mm3
•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 290
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 290

•1. Pregnancy or breastfeeding
•2. Terminally ill patients (life expectancy less than 4 weeks)
•3. Previous chemotherapy, other systemic therapy or radiotherapy of the current cancer disease
•4. Significant weight loss (= 20% body weight in the preceding 6 weeks)
•5. Current use of immunostimulant or immunosuppressive agents except therapeutics within the routinely administered standard therapy (e.g. corticosteroids for anti-emesis)
•6. Current use of any investigational agent or participation in a clinical trial during the last 4 weeks
•7. Drug abuse, alcohol abuse, methadone treatment
•8. Second primary malignancy in the last 5 years
•9. Known intracranial and spinal tumours and/or metastases
•10. Clinically significant concomitant disease critically influencing the ability of the patient to protocol adequate behaviour
•11. Co-morbidity with one of the following: chronic granulomatous diseases (incl. Tbc), hyperthyroidism with tachycardia, HIV infection/AIDS, other severe systemic diseases such as cardiac insufficienc (NYHA Stadium III - IV), parasitosis or Crohn's disease, acute inflammatory diseases with body temperature > 38°C, and other high febrile or autoimmune diseases
•12. Assured allergy to mistletoe-containing products.

发起方

Verein für Krebsforschung