Influence of intraperitoneal application of taurolidine on the perioperative metastases, tumor recurrence and survival rate after surgical resection of colorectal cancer
| ISRCTN | ISRCTN43522674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43522674 |
| Protocol serial number | N/A |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funder | Funding of the Insurance (Gehrling-Konzern) Vers.Nr.: 70-5644584-4 by Böhringer Ingelheim (Germany) |
- Submission date
- 15/03/2005
- Registration date
- 05/05/2005
- Last edited
- 06/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christoph Andreas Jacobi
Scientific
Scientific
Charité - University Medicine Berlin
Department of Surgery
Schumannstraße 20/21
Berlin
10117
Germany
| Phone | +49 30450522031 |
|---|---|
| christoph.jacobi@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | IPAT-MET |
| Study objectives | Recurrence rates after colon resection for cancer are 16% to 18% (Surgical Therapy Study Group). The study hypothesis is that the intraoperative intraperitoneal lavage with taurolidine reduces the 5-year recurrence rate from 16% to 10%. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | 2000 patients with colorectal cancer will be randomised to receive either taurolidine or NaCl solution during resection. Tumor recurrence, metastases and survival rates will be investigated up to 5 years. Intraoperative instillation of 1% taurolidine versus 0.9% NaCl solution, evaluation of morbidity and mortality, side-effects, long-term follow-up after 3, 6, 12 month and 2, 3, 4 and 5 years. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Taurolidine |
| Primary outcome measure(s) |
Time to local and distant tumor relapse (disease free survival). |
| Key secondary outcome measure(s) |
Global survival time. |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 2000 |
| Key inclusion criteria | Patients with colorectal cancer and curative resection, age over 18 years, American Society of Anesthesiologists (ASA) classification <IV. |
| Key exclusion criteria | 1. Ileus 2. Peritoneal carcinomatosis 3. Intraperitoneal abscess formation 4. Intestinal perforation 5. Peritonitis 6. Sepsis 7. Organ falure 8. ASA classification IV 9. R1 or R2 resection |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - University Medicine Berlin
Berlin
10117
Germany
10117
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
