Phase III study to determine the role of radiotherapy in patients with locally advanced pancreatic cancer: gemcitabine with and without chemoradiotherapy and with or without erlotinib

Australasian Gastro-Intestinal Trial Group (AGITG)0 个研究点目标入组 60 人开始时间: 2009年3月25日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Age older than 18yrs.
•2. Patients with de novo locally advanced, histologically proven adenocarcinoma of the
•pancreas without distant metastases (stage III according to the International Union against Cancer (UICC) classification) and
•not considered for curative resection after pluridisciplinary discussion.
•3. Eastern Cooperative Oncology Group (ECOG) Performance Status no less then 2
•4. Estimated life expectancy greater then 12 weeks
•5. No prior radiotherapy nor chemotherapy for any reason
•6. Signed informed consent form
•7. Polynuclear neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and hemoglobin = 9 g/dL
•8. Total bilirubin smaller or equal to 1.5 N (N: upper limit of normal). In patients who have had a recent
•biliary drain and whose bilirubin is descending, a value of smaller or equal to 3 N (50 µmoles/L) is
•acceptable.
•9. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) smaller or equal to 2.5 N, alkaline phosphatase smaller or equal to 5 N
•10. Albumin = 25 g/L
•11. Creatinin £ 177 mmol/L (2 mg/dL)
•12. Female patients who are not menopausal and their partners must accept to use effective
•contraception throughout treatment and for 3 months after the end of treatment. All
•patients who are capable of becoming pregnant must take a pregnancy test which is
•negative within 72 hours before beginning treatment. The definition of effective
•contraception is left up to the decision of the investigator.

•1. Localized stage IA to IIB or metastatic cancer (stage IV) according to UICC
•2. Previous chemotherapy for any reason
•3. Previous abdominal radiotherapy
•4. Allergy to one of ingredients in erlotinib
•5. Prior treatment with an anti-EGFR
•6. Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the
•uterus or basal cell skin cancer.
•7. Severe infection
•8. Ophthalmic disease (inflammation, keratopathy or infection)
•9. Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the
•last 6 months.
•10. Unable to take oral treatments or with gastrointestinal disorders that could be associated
•with absorption disorders, untreated gastric or duodenal ulcer.
•11. Pregnancy or breast feeding
•12. Unable to follow for psychological, familial or geographic reasons.
•13. Not affiliated with a social security regime.
•14. Diarrhea = grade 2 and/or uncontrolled diarrhoea

发起方

Australasian Gastro-Intestinal Trial Group (AGITG)