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 |
| Secondary identifying numbers | Slovenian Research Agency (ARRS) ref: P3-0321 |
- 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
Scientific
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
Study information
| Study design | Phase II, randomised, single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2003 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
1000
Slovenia
Sponsor information
Ministry of Higher Education, Science and Technology (Slovenia)
Government
Government
Kotnikova 38
Ljubljana
1000
Slovenia
| Website | http://www.mvzt.gov.si/en |
|---|---|
"ROR" |
https://ror.org/0452h9305 |
Funders
Funder type
Government
Ministry of Higher Education, Science and Technology (Slovenia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
