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

ISRCTN ISRCTN19912492
DOI https://doi.org/10.1186/ISRCTN19912492
Protocol serial number Slovenian Research Agency (ARRS) ref: L3-6059
Sponsor Ministry of Higher Education, Science and Technology (Slovenia)
Funder Ministry of Higher Education, Science and technology (Slovenia)
Submission date
13/08/2008
Registration date
29/08/2008
Last edited
23/07/2015
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 designInterventional
Study designProspective randomised single-centre phase II trial
Secondary study designRandomised controlled trial
Scientific titleProspective 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
Study objectivesThere 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(s)National Medical Ethics Committee, Ministry of Health, 09/12/2003, ref: 135/12/03
Health condition(s) or problem(s) studiedInoperable liver metastases of colorectal cancer
InterventionThe 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 typeDrug
PhasePhase II
Drug / device / biological / vaccine name(s)Cepecitabin and Irinotecan
Primary outcome measure(s)

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)

Key secondary outcome measure(s)

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)

Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexAll
Target sample size at registration100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Slovenia

Study participating centre

Institute of Oncology Ljubljana
Ljubljana
1000
Slovenia

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 22/04/2009 Yes No
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