A phase III, multicentre randomised clinical trial comparing gemcitabine alone or in combination with capecitabine for the treatment of patients with advanced pancreatic cancer
- Conditions
- Advanced Pancreatic CancerPancreaticCancer
- Registration Number
- ISRCTN11513444
- Lead Sponsor
- Sponsor not defined (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 508
1. Age >18 years
2. Histologically or cytologically proven ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
3. The presence of locally advanced or metastatic disease precluding curative surgical resection
4. Patients with macroscopic residual disease following resection confirmed by positive histology in post-resection tissue biopsies from the tumour bed (R2 resection) are also eligible
5. Unidimensionally measurable disease as assessed by computed tomography (CT) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. The only exception will be for patients with an R2 resection who will be evaluated for survival only.
6. No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication
7. No previous preoperative or adjuvant chemotherapy, radiotherapy or other investigational drug treatment
8. World Health Organisation (WHO) performance status 0, 1 or 2
9. Adequate bone marrow function with platelets >100 x 10^9/l; white blood cells (WBC) >3 x 10^9/l; neutrophils >1.5 x 10^9/l at the time of study entry
10. Serum bilirubin <35 µmol/l
11. Serum creatinine <180 µmol/l and calculated creatinine clearance over 50 ml/min
12. No concurrent uncontrolled medical condition
13. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
14. Life expectancy >3 months
15. Adequate contraceptive precautions if relevant
16. Informed written consent
1. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent
2. Intracerebral metastases or meningeal carcinomatosis
3. New York Heart Association classification Grade III or IV
4. Uncontrolled angina pectoris
5. Pregnancy or breast feeding
6. Impaired renal function with calculated creatinine clearance less than 50 ml/min
7. Previous investigational study drug
8. Known malabsorption syndromes
9. Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One-year survival.
- Secondary Outcome Measures
Name Time Method 1. Quality of life<br>2. Median and 2-year survival rates <br>3. Toxicity <br>4. Objective response rates<br>5. Assessment of pain