sing taurolidine to attenuate the surgically-induced endotoxaemia and the subsequent inflammatory response in patients with primary non-metastatic colon cancer

Not Applicable

Completed

• Conditions: Colon cancer; Cancer

• Registration Number: ISRCTN77829558
• Lead Sponsor: Geistlich Pharma AG (Switzerland)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30081854

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-06
• Study Completion: 2009-06-01
• Last Update Posted: 27 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Initial information at time of registration:
1. Patients of both genders who are 18 to 75 years of age
2. Patients with a solitary, non-metastatic extraperitoneal colonic tumour that already has been histologically confirmed
3. Patient has given full written informed consent
4. Elective setting

Added as of 25/11/2008:
5. Negative pregnancy test in women of childbearing age

Exclusion Criteria

Amended as of 25/11/2008:
1. Rectal tumours (within 15 cm of the anal orifice)
2. Known allergy to taurolidine/taurine
3. Pregnant and lactating women
4. Liver disease:
4.1. Abnormal liver function tests (LFTs) greater than 2 times upper limit of normal (ULN)
4.2. International normalised ratio (INR) greater than 1.5
5. Renal disease:
5.1. Creatinine greater than 180 (women), greater than 150 (men)
5.2. Serum sodium less than 132 or greater than 145
6. Blood dyscrasia:
6.1. Neutropenia less than 1500 cells/cm^3
6.2. Thrombocytopenia less than 100,000 cells/cm^3
7. Intestinal obstruction
8. Infiltration of adjacent organs
9. Tumour diameter greater than 8 cm on computed tomography (CT) scan
10. Severe obesity (body mass index greater than 32 kg/m^2)
11. Operative risk greater than American Society of Anaesthesiologists (ASA) - III
12. Another cancer/malignant disease other than non melanoma skin cancer
13. Coexisting active inflammatory disorder (including active Rheumatoid Arthritis [RA], Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE])
14. Immunocompromised:
14.1. Corticosteroids
14.2. Immunosuppressive drugs
14.3. Patients with human immunodeficiency virus (HIV), chronic active hepatitis B or C virus
15. Active infection

Initial information at time of registration:
1. Known allergy to taurolidine/taurine
2. Pregnancy and lactation
3. Liver disease (abnormal Liver Function Test [LFT's] results or International Normalised Ratio [INR] greater than 1.5)
4. Renal disease
5. History of electrolyte imbalance
6. Blood dyscrasia (neutropenia less than 1500 cells/cm^3, thrombocytopenia less than 100,000 cells/cm^3)
7. Intestinal obstruction
8. Infiltration of adjacent organs
9. Tumour diameter greater than 8 cm on Computerised Tomography (CT) scan
10. Severe obesity (body mass index greater than 32 kg/m^2)
11. Operative risk greater than American Society of Anaesthesiologists (ASA) grade III
12. Another cancer/malignant disease
13. Another chronic inflammatory disorder (e.g. Rheumatoid Arthritis [RA], Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE])
14. Immunocompromised
15. Active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified