Condition category
Cancer
Date applied
15/03/2005
Date assigned
05/05/2005
Last edited
06/02/2008
Prospective/Retrospective
Prospectively 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

Prof Christoph Andreas Jacobi

ORCID ID

Contact details

Charité - University Medicine Berlin
Department of Surgery
Schumannstraße 20/21
Berlin
10117
Germany
+49 30450522031
christoph.jacobi@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

IPAT-MET

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Taurolidine

Primary outcome measures

Time to local and distant tumor relapse (disease free survival).

Secondary outcome measures

Global survival time.

Overall trial start date

01/06/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with colorectal cancer and curative resection, age over 18 years, American Society of Anesthesiologists (ASA) classification <IV.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

2000

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Charité - University Medicine Berlin
Berlin
10117
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Department of Surgery
Schumannstraße 20/21
Berlin
10117
Germany

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Funding of the Insurance (Gehrling-Konzern) Vers.Nr.: 70-5644584-4 by Böhringer Ingelheim (Germany)

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

N/A

Publication citations

Additional files

Editorial Notes