Condition category
Cancer
Date applied
03/09/2008
Date assigned
13/11/2008
Last edited
17/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janja Ocvirk

ORCID ID

Contact details

Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

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 measures

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

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

http://www.mvzt.gov.si/en

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21399488

Publication citations

  1. 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.

Additional files

Editorial Notes