|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
27 May 2013 |
|
Main ID: |
NTR416 |
|
Date of registration:
|
20/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
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.
|
|
Scientific title:
|
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. - ECC |
|
Date of first enrolment:
|
1/2/2005 |
|
Target sample size:
|
43 |
|
Recruitment status: |
recruiting |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=416 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
S.
Sleijfer |
|
Address:
|
Erasmus Medical Center - Daniel den Hoed,
Department of Medical Oncology,
Groene Hilledijk 301, Groene Hilledijk 301
3075 EA
Rotterdam
The Netherlands |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
S.
Sleijfer |
|
Address:
|
Erasmus Medical Center - Daniel den Hoed,
Department of Medical Oncology,
Groene Hilledijk 301, Groene Hilledijk 301
3075 EA
Rotterdam
The Netherlands |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Histologically proven, irresectable gastric adenocarcinoma, except carcinoma of the cardia, WHO 0-2, ability to swallow, adequate hepatic, renal and bone marrow function.
Exclusion criteria: Prior chemotherapy or radiotherapy, current treatment with HMG-CoA-reductase inhibitor, peripheral neurotoxicity grade >2.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Gastric carcinoma
|
|
Intervention(s)
|
Control 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 Outcome(s)
|
|
Progression free survival rate (PFR) after 6 months.
|
|
Secondary Outcome(s)
|
|
Response rate scored according to the RECIST criteria, overall survival, quality of life, and toxicity graded according the international ?Common Toxicity Criteria?.
|
|
Secondary ID(s)
|
|
EMC 04-147
|
|
ISRCTN23062732
|
|
Source(s) of Monetary Support
|
|
Erasmus Medical Center, Department of Medical Oncology
|
|