Condition category
Cancer
Date applied
13/08/2008
Date assigned
29/08/2008
Last edited
23/07/2015
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: L3-6059

Study information

Scientific title

Prospective randomised clinical trial phase II: 5-fluorouracil/folinic acid (5-FU/FA) and irinotecan versus combination cepecitabin and irinotecan in patients with metastatic colorectal cancer as first line treatment

Acronym

Study hypothesis

There will be no statistically significant differences in efficacy, safety and survival of XELIRI regimen compared to standard FOLFIRI regimen in neoadjuvant setting of patients with unresectable liver-only metastases of colorectal cancer.

Ethics approval

National Medical Ethics Committee, Ministry of Health, 09/12/2003, ref: 135/12/03

Study design

Prospective randomised single-centre phase II trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Inoperable liver metastases of colorectal cancer

Intervention

The patients were randomised to either group A (XELIRI) or group B (FOLFIRI) (1:1 randomisation).

XELIRI regimen consisted of irinotecan (i.v.) 250 mg/m^2 given on Day 1 and capecitabine (oral) 1,000 mg/m^2 twice daily on Day 2-15, every 21 days.

FOLFIRI regimen consisted of irinotecan (i.v.) 180 mg/m^2, 5-fluorouracil (5-FU) (i.v.) 400 mg/m^2, leucovorin (LV) (i.v.) 200 mg/m^2, 5-FU (i.v.) 2,400 mg/m^2 (46-h infusion), all given on Day 1, every 14 days.

The patients in both groups received premedication with dexamethason 20 mg (intravenous [i.v.]), granisetron 1 mg i.v. and diazepam 10 mg i.v. on Day 1 of each chemotherapy cycle.

Planned treatment duration with chemotherapy was 24 weeks in both arms. In cases where the liver metastases became operable in response to the initial (neoadjuvant or preoperative) chemotherapy, radical (R0) resection of the metastases was performed.

Intervention type

Drug

Phase

Phase II

Drug names

Cepecitabin and Irinotecan

Primary outcome measures

During the therapy, the following were assessed at baseline, 3 and 6 months, thereafter follow-up was every 3 months until progression of the disease (no limit on the maximum duration of follow-up):
1. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
2. Rate of radical surgical resection (R0 resection)

Secondary outcome measures

During the therapy, the following were assessed at baseline, 3 and 6 months, thereafter follow-up was every 3 months until progression of the disease (no limit on the maximum duration of follow-up):
1. Safety
2. Progression-free survival (PFS)
3. Overall survival (OS)

Overall trial start date

01/01/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, age between 18-75 years
2. World Health Organization (WHO) performance status 0-1
3. Inoperable liver metastases of colorectal adenocarcinoma
4. No prior chemotherapy for metastatic disease
5. >6 months since adjuvant treatment
6. At least one measurable lesion visible on spiral computerised tomography (CT)
7. Adequate haematological, hepatic and renal function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Metastases outside of the liver
2. Local recurrence of colorectal cancer
3. Bilirubin >2 x upper limit of normal (ULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x ULN
4. Clinical signs of cardiac decompensation
5. Ischaemic heart disease
6. Inflammatory bowel disease
7. History of other cancer
8. Participation in other study protocol

Recruitment start date

01/01/2004

Recruitment end date

31/12/2006

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.vlada.si/?gr1=min&gr2=minSzt&gr3=&gr4=&id=&lng=eng

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

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19386096

Publication citations

Additional files

Editorial Notes