5-ALA in Bowel Cancer Surgery

Phase 1

• Conditions: Colon cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002623-15-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

•Able to give informed consent and willing to follow trial protocol
•Aged over 18
•Patients with cancers of the right and sigmoid colon amenable to laparoscopic resection incorporating D3 lymphadenectomy, as agreed by MDT discussion following histopathological diagnosis and radiological staging. Where possible, the study population will be enriched with locally advanced colon cancers to obtain as much information as possible on 5-ALA FD for lymph node metastases.
•Patients with distant metastatic disease will be eligible, provided laparoscopic resection of the cancer is part of routine clinical care.
•Fit for standard laparoscopic resection
•American Society of Anesthesiologists (ASA) classification = 3
•Normal hepatic and renal function
i)Total bilirubin within normal institutional limits, AST/ALT < 2.5 X institutional upper limit of normal
ii)Creatinine within normal institutional limits

Evaluation phase: a separate protocol and application will be submitted

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

•Patients with cancers of the transverse and left colon (due to difficulty in defining D3 lymphadenectomy in these anatomical locations)
•Past history of hypersensitivity reactions to 5-ALA or colorimetric dye.
•Acute or chronic porphyria or a family history
•Patients with synchronous colonic or rectal cancer (but not benign polyps)
•Patients with co-existent inflammatory bowel disease, such as Crohn’s disease, ulcerative colitis or active diverticulitis, which may influence the lymphatic uptake of 5-ALA
•Pregnant (positive pregnancy test) or breast feeding. 5-ALA has unknown teratogenic and abortifacient effects.
•Received an investigational medicinal product at any dose within 28 days before registration
•Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial.

Evaluation phase: a separate protocol and application will be submitted

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified