racil and ftorafur (UFT) and radiotherapy in patients with locally advanced pancreatic cancer
- Conditions
- Cancerocally advanced pancreatic cancerPancreatic cancer
- Registration Number
- ISRCTN65518365
- Lead Sponsor
- Royal Marsden NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One-year overall survival rate
- Secondary Outcome Measures
Name Time Method