|- candidate number||7688|
|- NTR Number||NTR2182|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jan-2010|
|- Secondary IDs||171002209 ZonMW|
|- Public Title||Frequent CEA measurements in follow-up of colorectal carcinoma.|
|- Scientific Title||Computer supported follow-up after curative treatment of colorectal cancer based on CEA.|
|- hypothesis||The percentage of curatively treatable metastatic disease after surgery for primary colorectal cancer can be increased by means of optimizing follow-up of colorectal carcinoma. Intensifying the follow-up by increasing frequency of CEA measurements, and performing CT scans if CEA rises, will reach the increase of this percentage. Curable treatment of metastatic disease is known to be associated with longer survival.|
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Follow-up, Carcinoembryonic antigen|
|- Inclusion criteria||1. Patients with stage II- III –IV colorectal carcinoma after curative resection (R0 resection) from 1-1-2007;|
2. All new patients with II-III-IV colorectal carcinoma eligible for curative resection;
3. Patients currently in follow-up, operated within 2 years after start study;
4. All patients need to be above 18 and capable of understanding the Dutch language.
|- Exclusion criteria||1. Patients with other malignancies except basocellular carcinoma of the skin;|
2. Patients not medically fit for metastasectomy;
3. Patients with diagnosed syn- or metachronous incurable metastases at time of start study;
4. No written informed consent.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2010|
|- planned closingdate||31-dec-2012|
|- Target number of participants||1800|
|- Interventions||After randomization at hospital level, all patients in that hospital will participate in the new follow-up scheme. This consists of increasing of the frequency of CEA measurement, and of performing an additinal CT scan if CEA values has risen significantly. |
All patients in the intervention group will be imported in a software program, which exactly follows all CEA values and gives information on rise in CEA. Thereby the program is able to inform the patients of their CEA values quickly. Using this software has shown to reduce the incidence of hospital visits for patients.
|- Primary outcome||The percentage of curatively treatable recurrent or metachronous metastatic disease in the intervention group in comparison with the control group.|
|- Secondary outcome||1. Disease free survival, recurrent-free survival, overall survival;|
2. Quality of Life in patients undergoing more intensified follow-up schemes;
3. Costs and effectiveness of introducing a software tool to support the frequent CEA measrurements.
|- Timepoints||1. 1-10-2010: Start interventions schedule in firstly randomized participating hospitals;|
2. 1-10-2011: Start intervention schedule in last randomized participating hospitals;
3. 1-7-2012: Stop intervention.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD C. Verberne|
|- CONTACT for SCIENTIFIC QUERIES|| T. Wiggers|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||In this prospective randomized trial, a new follow-up protocol for patients curatively treated for colorectal cancer (CRC) is introduced. A national guideline for follow-up after CRC already exists, but adherence to this guideline is variable. |
In the study, 10 Dutch hospitals will participate. Randomization is on hospital level, which practically means that a hospital is performing follow-up in the way it's used to, and after randomization, all patients in that hospital will participate in the new schedule, resulting in the fact that the last-randomized hospital will produce a large dohort of control group and a small cohort of intervention group patients.
In the intervention group, CEA will be measured more frequently and further imaging will be performed in case of rise in CEA. Of course regular imaging using CT scan and colonoscopy will be performed as well.
In monitoring this follow-up, a software tool called CEA-watch is used, which attends the surgeon when a patient has an increased CEA value and can easily produce letters and emails for informing patients.
Aim of this study is to find metastatic disease earlier than in regular follow-up, thereby increasing the chance to curatively treat these metastases.
|- Main changes (audit trail)|
|- RECORD||26-jan-2010 - 9-feb-2010|