To evaluate the effectiveness of optimization of CEA measurements after curative resection of stage II, III and IV colorectal carcinoma. The short-term effectiveness will be quantified in percentage of patients that are eligible for curative…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients eligible for curative resection of liver- or lung
metastasis
Secondary outcome
Calculation of the optimal threshold values and measurement frequency of CEA
The correlation between CEA and helical CT abdomen/thorax: specifically whether
the metastasis can be localised when CEA values suggest metastastatic disease.
Evaluation of the logistic feasibility of the proposed follow-up scheme
Background summary
The primary goal of follow-up after curative treatment of cancer is to detect
curable local recurrence or distant metastasis. In colorectal carcinoma
potentially curable recurrent disease includes liver- and lung metastasis and
sometimes local recurrence. Serum CEA as a tumour marker is an effective and
cost-efficient method for early detection of recurrent disease and is the core
in current follow-up guidelines. Up to now however, follow-up has not been very
effective for prolonging survival.
A previous study has been undertaken to investigate why CEA, despite its
theoretical capacities, has failed to prolong survival in clinical practice.
Various reasons why CEA was not effective to increase survival could be
determined; Method related reasons are the measurement frequency, threshold
interpretation and anticipation on expected time of recurrent disease. Clinical
reasons have been the ineffective utilization of the achieved lead time, mainly
because suspected recurrent disease could not be localized, the delay in
treatment and the limited treatment options, all in comparison to the present
situation. Logistic reasons have been the limited adherence to follow-up
guidelines by doctors and patients, including failure to testing due to false
assumptions about CEA. General conclusion is that with relatively simple
adaptations the effectiveness of CEA on early detection of recurrent disease
might be increased significantly.
Study objective
To evaluate the effectiveness of optimization of CEA measurements after
curative resection of stage II, III and IV colorectal carcinoma. The short-term
effectiveness will be quantified in percentage of patients that are eligible
for curative metastasectomy of liver- and lung metastasis.
Study design
Multicentre prospective fase II study
Intervention
Monthly measurement CEA from blood sample in the 2 years after curative
resection.
Instead of CEA measurement every 3 months as advised in the current guidelines.
Study burden and risks
- Haematoma from vena puncture
- Anxiety caused by frequent vena punctures
Haaksbergerstraat 55
7513 ER Enschede
NL
Haaksbergerstraat 55
7513 ER Enschede
NL
Listed location countries
Age
Inclusion criteria
All patients with stage II-III-IV colorectal carcinoma that had curative treatment and are medically fit for metastasectomy. Patients should be above 18 and not mentally incapacitated
Exclusion criteria
Patients not medically fit for metastasectomy
Patients with diagnosed syn- or metachronous incurable metastasis at time of inclusion
No written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15366.042.07 |