Prospective randomised phase II clinical trial of epirubicin, cisplatin, continuous infusional 5-fluorouracil (ECF) versus epirubicin, cisplatin and capecitabin (ECX) in patients with advanced gastric cancer

ISRCTN	ISRCTN72792659
DOI	https://doi.org/10.1186/ISRCTN72792659
Protocol serial number	Slovenian Research Agency (ARRS) ref: P3-0321
Sponsor	Ministry of Higher Education, Science and Technology (Slovenia)
Funder	Ministry of Higher Education, Science and Technology (Slovenia)

Submission date: 03/09/2008
Registration date: 13/11/2008
Last edited: 17/07/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Janja Ocvirk
Scientific

Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

Study information

Primary study design	Interventional
Study design	Phase II, randomised, single-centre trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	The National Medical Ethics Committee, Ministry of Health. Date of approval: 11/06/2002 (ref: 92/06/02)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Epirubicin, cisplatin, 5-fluorouracil, capecitabin
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/01/2003
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

Slovenia

Study participating centre

Institute of Oncology Ljubljana

Ljubljana
1000
Slovenia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No