Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Slovenian Research Agency (ARRS) ref: P3-0321
Study information
Scientific title
Acronym
Study hypothesis
Null hypothesis: There will be no statistically significant difference in efficacy, safety and survival of ECX (epirubicin, cisplatin, capecitabin) regimen compared to ECF (epirubicin, cisplatin, continuous infusional 5-fluorouracil) regimen in patients with advanced gastric cancer.
Ethics approval
The National Medical Ethics Committee, Ministry of Health. Date of approval: 11/06/2002 (ref: 92/06/02)
Study design
Phase II, randomised, single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Advanced gastric cancer
Intervention
This trial took place at the Institute of Ljubljana (single-centre trial).
Patients were randomised to ECF or ECX chemotherapy group in equal numbers:
ECF consisted of epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 by intravenous injection, 5-FU 200 mg/m^2/day was administrated by continuous infusion on Day 1-14 of each cycle. Cycle was repeated every 3 weeks.
In ECX combination epirubicin 50 mg/m^2 and cisplatin 60 mg/m^2 were administrated on Day 1 by intravenous injection. Capecitabine 825 mg/m^2 twice daily was administrated orally on Day 1-14. Cycle was repeated every 3 weeks.
Treatment was continued until disease progression, unacceptable toxicity occurred or the patient refused further treatment.
Intervention type
Drug
Phase
Phase II
Drug names
Epirubicin, cisplatin, 5-fluorouracil, capecitabin
Primary outcome measure
Response rate, assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)
The primary and secondary outcomes were assessed at baseline, 3 and 6 months during therapy, then follow-up was performed every 3 months until progression of disease.
Secondary outcome measures
1. Safety
2. Progression-free survival (PFS)
3. Overall survival (OS)
The primary and secondary outcomes were assessed at baseline, 3 and 6 months during therapy, then follow-up was performed every 3 months until progression of disease.
Overall trial start date
01/01/2003
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, age 18 years or older
2. Histologically confirmed advanced gastric cancer
3. Performance status of 0-2
4. Adequate bone marrow function
5. Adequate renal, hepatic function
7. Normal cardiac function
8. Estimated life expectancy more than 3 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Performance status more than 2
2. Patients not recovered from operation
3. Patients with unresolved intestinal obstruction
4. Malabsorption syndrome
5. Pregnancy
6. Breastfeeding or childbearing potential without using adequate contraception
7. Cardiovascular diseases (New York Heart Association [NYHA] III-IV)
8. Impaired renal function
9. Liver diseases
10. Active hepatitis (hepatitis B, hepatitis C)
11. HIV positive
12. Other active infection
Recruitment start date
01/01/2003
Recruitment end date
31/03/2007
Locations
Countries of recruitment
Slovenia
Trial participating centre
Institute of Oncology Ljubljana
Ljubljana
1000
Slovenia
Sponsor information
Organisation
Ministry of Higher Education, Science and Technology (Slovenia)
Sponsor details
Kotnikova 38
Ljubljana
1000
Slovenia
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Higher Education, Science and Technology (Slovenia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21399488
Publication citations
-
Results
Ocvirk J, Reberšek M, Skof E, Hlebanja Z, Boc M, Randomized prospective phase II study to compare the combination chemotherapy regimen epirubicin, cisplatin, and 5-fluorouracil with epirubicin, cisplatin, and capecitabine in patients with advanced or metastatic gastric cancer., Am. J. Clin. Oncol., 2012, 35, 3, 237-241, doi: 10.1097/COC.0b013e31820dc0b0.