Colon cancer MedDRA version: 17.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Gliolan
Product Name: Gliolan
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: 5-aminolevulinic acid (5-ALA)
CAS Number: 5451-09-2
Concentration unit: mg/ml milligram(s)/
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to give informed consent and willing to follow trial protocol 2. Aged over 18 3. 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. 4. Patients with distant metastatic disease will be eligible, provided laparoscopic resection of the cancer is part of routine clinical care. 5. Fit for standard laparoscopic resection 6. American Society of Anesthesiologists (ASA) classification = 3 7. Normal hepatic and renal function on most recent blood tests (to be within 30 days prior to surgery). For the purposes of the trial a normal hepatic renal function can be defined as: i) Total bilirubin within normal institutional limits, ii) AST/ALT or = 60mls/min/1.73m2 or Creatinine within 10% of upper value for 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
Exclusion criteria: 1. Patients with cancers of the transverse and left colon (due to difficulty in defining D3 lymphadenectomy in these anatomical locations) 2. Past history of hypersensitivity reactions to 5-ALA or colorimetric dye. 3. Acute or chronic porphyria or a family history 4. Patients with synchronous colonic or rectal cancer (but not benign polyps) 5. 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 6. Pregnant (positive pregnancy test) or breast feeding. 5-ALA has unknown teratogenic and abortifacient effects. In women of childbearing potential (defined as any female who has experienced menarche and who is not postmenopausal or permanently sterilised e.g. tubal occlusion, hysterectomy, bilateral salpingectomy), a pregnancy test will be performed and evidence of a negative result will be required prior to entry into the study. In females of child bearing potential, or those patients with partners of child bearing potential, trial investigators will advise on appropriate contraception (e.g. barrier method) from the point of registration to 30 days postop. 7. Received an investigational medicinal product at any dose within 28 days before registration 8. 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. Where possible, the study population will be enriched with locally advanced colon cancers (CT findings of a T4 tumour, T3 tumours with and extramural depth of > 5mm, as per FOcTROT definition) to obtain as much information as possible on 5ALA for lymph node metastases. Concerns regarding a patient's eligibility can be discussed with the St John's University Hospital Leeds' Research Fellow, or with the Chief Investigator. [Evaluation phase: a separate protocol and application will be submitted]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To optimise the dose of oral 5-ALA administration for intra-operative fluorescence diagnosis of metastatic lymph nodes in colon cancer. ;Secondary Objective: 1) Establish a reliable and repeatable methodology for fluorescence diagnosis of lymph node metastasis by standardisation of: i) pre-operative CT lymph node reporting ii) intra-operative fluorescence detection system iii) surgical technique for laparoscopic segmental colonic resection with D3 lymphadenectomy iv) histopathogical examination of resected specimens. 2) identify systemic, operative and patient factors which adversely affect the intraoperative detection of lymph node fluorescence. ;Primary end point(s): We aim to undertake a two-staged investigation Developmental Phase: Identification of the optimal dose for oral administration of 5-ALA for the accurate intra-operative detection of lymph node metastases. Evaluation Phase: a separate protocol and application will be submitted for this phase.;Timepoint(s) of evaluation of this end point: Both centres will recruit at least 20 patients over a period of 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Establish a reliable and repeatable methodology for fluorescence diagnosis of lymph node metastasis by standardisation of: i) pre-operative CT lymph node reporting ii) intra-operative fluorescence detection system iii) surgical technique for laparoscopic segmental colonic resection with D3 lymphadenectomy iv) histopathogical examination of resected specimens. 2) identify systemic, operative and patient factors which adversely affect the intraoperative detection of lymph node fluorescence. ;Timepoint(s) of evaluation of this end point: Both centres will recruit at least 20 patients over a period of 18 months | — |
Countries
Ireland, United Kingdom
Contacts
Public ContactCatherine Lowe
Clinical Trials Research Unit
Outcome results
None listed