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 |
| Secondary identifying numbers | Slovenian Research Agency (ARRS) ref: L3-6059 |
- 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
Scientific
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
Study information
| Study design | Prospective randomised single-centre phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | National Medical Ethics Committee, Ministry of Health, 09/12/2003, ref: 135/12/03 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Cepecitabin and Irinotecan |
| Primary outcome measure | 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 study start date | 01/01/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2006 |
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.vlada.si/?gr1=min&gr2=minSzt&gr3=&gr4=&id=&lng=eng |
|---|---|
"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 | 22/04/2009 | Yes | No |
