ISRCTN65518365已完成2 期
A multicentre randomised phase II clinical study of uracil and ftorafur (UFT) and radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer
Royal Marsden NHS Foundation Trust (UK)0 个研究点目标入组 90 人开始时间: 2010年10月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged greater than or equal to 18 years, either sex
- •2. Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas
- •3. Considered to be unresectable based on at least one of the following:
- •3.1. Extensive peri-pancreatic lymph node involvement
- •3.2. Encasement or occlusion of the superior mesenteric vein (SMV) or SMV/portal vein confluence
- •3.3. Direct involvement of superior mesenteric artery (SMA), coeliac axis, inferior vena cava (IVC) or aorta
- •4. World Health Organization (WHO) performance status 0 - 2
- •5. No evidence of metastatic disease as determined by computed tomography (CT) scan (chest, abdomen and pelvis) or other investigations
- •6. Adequate bone marrow function with platelets greater than or equal to 100 x 10^9/l, white blood cells (WBC) greater than or equal to 3 x 10^9/l and neutrophils greater than or equal to 1.5 x 10^9/l
- •7. Serum bilirubin less than 1.5 x upper limit of institutional normal range (ULN) and transaminases less than or equal to 2.5 x ULN
- •8. Calculated/measured glomerular filtration rate (GFR) greater than or equal to 50 ml/min (either calculated by Cockcroft and Gault formula or measured as per usual local procedure)
- •9. No concurrent uncontrolled medical condition
- •10. No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years
- •11. Life expectancy greater than 3 months
- •12. Adequate contraceptive precautions if relevant
- •13. Informed written consent
排除标准
- •1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- •2. Presence of metastatic disease
- •3. Concurrent uncontrolled medical conditions
- •4. Any previous chemotherapy or radiotherapy, and any investigational treatment for advanced pancreatic cancer
- •5. Adjuvant chemotherapy with fluoropyrimidine or gemcitabine within 12 months of trial entry
- •6. Adjuvant radiotherapy with or without chemotherapy for pancreatic cancer
- •7. Pregnancy or breast feeding
- •8. Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
- •9. Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency
- •10. Clinically significant (i.e. active) cardiovascular disease. This includes, but is not limited to, the following examples:
- •10.1. Cerebrovascular accidents (less than or equal to 6 months prior to registration)
- •10.2. Myocardial infarction (less than or equal to 1 year prior to registration)
- •10.3. Uncontrolled hypertension (greater than 150/100 mmHg) while receiving chronic medication
- •10.4. Unstable angina
- •10.5. New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •10.6. Serious cardiac arrhythmia requiring medication
- •10.7. Clinically significant electrocardiogram (ECG) findings (e.g. QTc greater than or equal to 440 msecs [male] 460 msecs [female] or greater than or equal to 2º AV Block, etc.).
- •Patients who suffer from serious cardiac arrhythmia requiring medication can enter the study only if they are considered to be in a stable condition regarding both the arrhythmia and their medication. Patients with pacemakers are allowed to enter the study only if they are considered as being in a stable condition. In case of doubt, the investigator should obtain a consultation with a local cardiologist.
研究者
相似试验
进行中（未招募）
1 期
A multicentre randomised phase II clinical study of UFT/leucovorin (LV), radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer - PEREUCTR2008-000517-30-GBThe Royal Marsden Hospital NHS Trust17
进行中（未招募）
1 期
A trial testing a new agent for patients with diffuse large B cell lymphoma (DLBCL) who have heart conditions and unable to receive standard treatmentDiffuse large B cell lymphomaMedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001900-39-GBniversity College London132
进行中（未招募）
1 期
A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magnetic resonance imaging (MRI) defined high risk rectal cancer. - EXPERT-CHigh risk operable rectal adenocarcinomaMedDRA version: 13.1 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-004707-38-GBRoyal Marsden NHS Trust164
已完成
不适用
A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magentic resonance imaging defined high risk rectal cancerRectal cancerCancerISRCTN99828560Royal Marsden NHS Foundation Trust (UK)164
进行中（未招募）
不适用
A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magnetic resonance imaging (MRI) defined poor risk rectal cancer. - EXPERT-CPoor risk operable rectal adenocarcinomaEUCTR2004-004707-38-SEProf David Cunningham164