To increase the amount of curatively treatable metastasis and recurrences of CRCandmaking an evidence-based guideline for the use of CEA in the follow-up of CRC
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of curatively treatable recurrences and/or metastases in the
intensive follow-up arm has to be > 15% higher than the percentage in the
control group
Secondary outcome
Survival, disease-free and recurrence free survival per follow-up arm
Background summary
CEA is a serum tumormarker used in follow-up for colorectal cancer in early
diagnosis of recurrent disease or metachronous metastatic disease. If
metastases or recurrences are diagnosed early, the percentage of curative
treatment increases and with curative treatment, the overall survival of these
patients increases.
The national guideline for determining and interpreting of CEA is not uniform
and adherence of surgeons is low. There is need to optimize the follow-up of
CRC with CEA as a cheap, available and sensitive marker.
Study objective
To increase the amount of curatively treatable metastasis and recurrences of CRC
and
making an evidence-based guideline for the use of CEA in the follow-up of CRC
Study design
Patients operated for CRC will be in follow-up after resection. To these
patients, an intensive follow-up with the frequent determination of CEA is
offered.
Approximately 10 hospitals join this study. The moment on which a hospital will
be participating is randomized. So, there is regular follow-up until
randomization and after this every patient will be offered the intensive
follow-up protocol.
Study burden and risks
In the intensive follow-up schema, patients have to undergo vena punctions more
often (every 8 weeks instead of every 12 weeks). Only the minimal risk
associated with vena punctions is added.
However, patients will have policlinic controls less often.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
TxNxMo colorectal carcinoma, histologically confirmed
operation date 01-01-2007 or later
>18 years
Exclusion criteria
fit for metastectomy
dementia
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 | NL31410.042.10 |