Contact information
Type
Scientific
Primary contact
Dr J. Wind
ORCID ID
Contact details
Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663170
J.Wind@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR277
Study information
Scientific title
Acronym
CTC-trial
Study hypothesis
We hypothesise that free circulating tumour cells can be detected during surgery in patients with colorectal cancer. Since minimal invasive surgery causes less trauma and tumour manipulations we hypothesise that the amount of free circulating tumour cells is less compared to the level detected during open surgery in comparable patient groups. Minimal invasive surgery causes less severe impairment of the immune system compared to open surgery. Since the surgical trauma might enhance tumour shedding and compromises immune function, the minimally invasive surgery for colorectal cancer might both lower the risk of tumour shedding and result in less compromised immune down-regulation resulting in better protection against tumour shedding.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Colorectal cancer
Intervention
Laparoscopic surgery compared to open surgery for colorectal cancer.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The amount of circulating tumour material induced by the surgical procedure, measured before, during and after the surgical procedure.
Secondary outcome measures
1. The level of cytokines before, during and after the surgical procedure
2. Differences in genotype between primary tumour and circulating tumour cells
Overall trial start date
01/07/2005
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Prior midline laparotomy
2. American Society of Anaesthesiologists (ASA) grade III/IV
3. Laparoscopic surgeon not available
4. Prior upper and/or lower midline laparotomy
5. Emergency colectomy
6. Contraindications for epidural (coagulation disorders)
Recruitment start date
01/07/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Internal funding
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