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van CCT (UK)


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van CCT (UK)


A randomized phase II trial comparing epirubicin, cisplatin, and capecitabine versus the combination of epirubicin, cisplatin, and capecitabine with pravastatin in patients with irresectable or metastatic gastric carcinoma.


- candidate number1712
- NTR NumberNTR416
- ISRCTNISRCTN23062732
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR20-sep-2005
- Secondary IDsEMC 04-147 
- Public TitleA randomized phase II trial comparing epirubicin, cisplatin, and capecitabine versus the combination of epirubicin, cisplatin, and capecitabine with pravastatin in patients with irresectable or metastatic gastric carcinoma.
- Scientific TitleA randomized phase II trial comparing epirubicin, cisplatin, and capecitabine versus the combination of epirubicin, cisplatin, and capecitabine with pravastatin in patients with irresectable or metastatic gastric carcinoma.
- ACRONYMECC
- hypothesisTreatment with capecitabine, combined with epirubicin and cisplatin (ECC) has been proven to improve time to progression and survival in patients with advanced, non-resectable gastric cancer. HMG-CoA-reductase inhibitors have anti-tumor activity in vitro against gastric carcinoma. Statins furthermore interact synergistically with cisplatin, 5-FU and doxorubicin both in vitro and animal models. As prognosis of advanced irresectable gastric cancer is poor, it is worthwhile to study whether the combination of ECC and pravastatin is an option for these patients.
- Healt Condition(s) or Problem(s) studiedGastric carcinoma
- Inclusion criteriaHistologically proven, irresectable gastric adenocarcinoma, except carcinoma of the cardia, WHO 0-2, ability to swallow, adequate hepatic, renal and bone marrow function.
- Exclusion criteriaPrior chemotherapy or radiotherapy, current treatment with HMG-CoA-reductase inhibitor, peripheral neurotoxicity grade >2.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2005
- planned closingdate1-jan-2008
- Target number of participants43
- InterventionsControl arm (ECC): epirubicin 50 mg/m2 i.v., day 1, Cisplatin 60 mg/m2 i.v., day 1, 3-hour infusion, Capecitabine 1000 mg/m2 in the morning and 1000 mg/m2 in the evening, p.o., day 1-14. ECC will be given at 3-week intervals, for a maximum total of 6 cycles. Experimental arm (ECC plus pravastatin): Epirubicin 50 mg/m2 i.v., day 1, Cisplatin 60 mg/m2 i.v., day 1, 3-hour infusion, Capecitabine 1000 mg/m2 in the morning and 1000 mg/m2 in the evening, p.o., day 1-14. ECC will be given at 3-week intervals, for a maximum total of 6 cycles. In addition, patients will receive daily 40 mg pravastatin, from day 1 to 1 week after the capecitabine of the last ECC.
- Primary outcomeProgression free survival rate (PFR) after 6 months.
- Secondary outcomeResponse rate scored according to the RECIST criteria, overall survival, quality of life, and toxicity graded according the international “Common Toxicity Criteria”.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. S. Sleijfer
- CONTACT for SCIENTIFIC QUERIESDr. S. Sleijfer
- Sponsor/Initiator Erasmus Medical Center, Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Medical Oncology
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD20-sep-2005 - 7-mrt-2006


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