NCT00662688.
Trial name or title | Chemotherapy with or without preventive anticoagulation for metastatic cancer of the pancreas |
Methods | Randomised, multicentre study. Methods of randomisation and allocation concealment unclear |
Participants | Patients with histologically confirmed adenocarcinoma of the pancreas (metastatic disease, not amenable to treatment, no localised or locally advanced disease) receiving treatment with different combinations of gemcitabine and capecitabine |
Interventions | Arm 1A: gemcitabine hydrochloride IV over 150 minutes on days 1 and 15 Arm 1B: gemcitabine hydrochloride as in arm 1A and LMWH, dalteparin sc on day 1 Arm 2A: gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral capecitabine every 12 hours on days 1 to 21 Arm 2B: gemcitabine hydrochloride and capecitabine as in arm 2A and LMWH, dalteparin sc as in arm 1B Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. |
Outcomes | Primary outcome measures: thromboembolic events Secondary outcome measures: thromboembolic‐related survival, progression‐free survival, overall survival, time to response of tumour, tolerance of regimens |
Starting date | October 2007 |
Contact information | Chibauldel B |
Notes |
NCT00662688 Note: The study status in ClinicalTrials.gov is "terminated". |