Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
Prospective/Retrospective
Retrospectively 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

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes