NCT01077427Unknown3 期
A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)
Klinikum der Universitaet Muenchen, Grosshadern1 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any ductal adenocarcinoma of the pancreas confirmed by histology
- •Previous R0 or R1 resection of pancreatic tumor with a standardized procedure
- •No other previous or concomitant treatment of pancreatic carcinoma like radiation, neoadjuvant therapy or immunotherapy
- •No tumor recurrence after surgery
- •Performance status ECOG 0-2
- •Adequate bone marrow function defined as
- •WBC count ≥ 3.5 x 109/L and
- •platelets ≥ 150 x 109/L and
- •haemoglobin ≥ 9 g/dl documented within 1 week prior to randomization
- •Adequate renal function defined as
- •serum creatinine ≤ 1.2 mg/dL and
- •calculated GFR ≥ 60 mL/min documented within 1 week prior to randomization
- •Adequate coagulatory function defined as
- •Quick-value ≥ 70% and
- •aPTT ≤ 1.5 x ULN documented within 1 week prior to randomization
- •Transaminases (AST, ALT) ≤ 3 x ULN and bilirubin ≤ 2 x ULN documented within 1 week prior to randomization
- •At least 18 years of age
- •Women with childbearing potential and fertile men must use adequate contraceptive measures during and for at least 3 months (female) and 6 months (male) after completion of study therapy (Adequate methods for women are oral contraceptives with estrogen and progesterone, vaginal rings, contraceptive patches, estrogen-free ovulation inhibitors, intrauterine devices with progesterone, 3-month injections with depot progesterone, implants setting free progesterone, abstinence or sterilization (vasectomy) of the male partner. Men must use condoms.)
- •Women with childbearing potential must have a negative pregnancy test within 1 week prior to randomization (postmenopausal women with amenorrhea for more than 1 year are regarded as having no childbearing potential)
- •Written informed consent
- •Exclusion criteria:
- •Cystic carcinoma of the pancreas
- •Periampullary, papillary cancer
- •Metastatic disease
- •Presence of an active infection grade 3 or higher
- •Other severe disease which could impair the patient's ability to participate in the study according to the investigator's opinion
- •Pregnant or breastfeeding women
- •Known allergies or contraindications with regard to substances or procedures of study therapy
- •Severe, non-healing wounds, ulcers or bone fractures
- •Participation in another clinical trial during this study or within 4 weeks prior to randomization (Exception: participation in a surgical trial prior to this study, for instance RECOPANC trial, comparing two different surgical procedures of pancreas resection)
- •Past or current abuse of illegal or legal drugs or alcohol
- •Other primary malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin).
- •Permanent cardiac pacemaker
- •Clinically significant cardiovascular or vascular disease or disorder ≤ 6 months before study enrolment (e.g. myocardial infarction, unstable angina pectoris, chronic heart failure NYHA ≥ grade 2, uncontrolled arrhythmia, cerebral infarction
- •Gross adiposity defined as BMI > 40 kg/m²
- •Treatment with regional hyperthermia not possible for technical reasons (e.g. metal implant)
- •"Known documented dihydropyrimidine dehydrogenase (DPD) deficiency"
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine + Capecitabine
Active Comparator
干预措施: Gemcitabine + Capecitabine (Drug)
Gemcitabine + Cisplatin + regional hyperthermia
Experimental
干预措施: Gemcitabine + Cisplatin + regional hyperthermia (Device)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
次要结局
- Overall survival (OS)(From date of randomization until the date of death from any cause assessed up to 60 months)
研究者
Rolf D. Issels
MD, PhD
Klinikum der Universitaet Muenchen, Grosshadern
研究点 (1)
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