Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225641
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2005-09-22
Brief Title:
Assessment of Frequency of Surveillance After Curative Resection in Patients With Stage II and III Colorectal Cancer
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
COLOFOL - A Pragmatic Study to Assess the Frequency of Surveillance Tests After Curative Resection in Patients With Stage II and III Colorectal Cancer - a Randomised Multicentre Trial
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim is to conduct a prospective multicentre randomised study comparing two different control regimens after resection for colorectal cancer stage II - III Follow-up after surgery for colorectal cancer is a controversial issue The reasons for follow-up are to obtain a better overall survival for scientific purposes andor for psychological reasons andor as quality assessment Meta-analyses of randomised controlled studies have lately shown that a beneficial effect on the overall mortality could be found with intense follow-up compared to sporadic This study compares the regimen of CT-scan or MR scan of the liver control of the carcinoembryonic antigen CEA and CT-scan or X-ray of the lungs in two groups with either control after 12 and 36 months or after 6 12 18 24 and 36 months The efficacy parameters are total and cancer-specific mortality
Detailed Description:
The aim is to investigate the efficiency of two follow-up programs after radical surgery for colorectal cancer Colorectal cancer attacks between 3-5 of the European population during their lifetime and about 75 of these will have potential curative surgery performed Follow up after surgery is costly and time consuming for both patients and the Health Care Systems The intensity of follow up as well as the methods employed vary tremendously from center to centre and from country to country Until recently the scientific documentation for the cost-effectiveness of follow-up was very sparse but recent compiling of data indicates that intense follow up can save lives as compared to sporadic follow-up at an acceptable cost However the optimal follow-up intervals and the best methods are unknown Previous results indicate that scanning of the liver and measuring of the tumor-marker CEA may be a way forward A prospective randomised multicenter study in centers from Denmark approx 15 Sweden approx 20 Poland approx 6 Hungary approx 2 and perhaps The Netherlands and UK is starting in 2005 after basic work with protocols ethical committees now has been finished This basic work was supported by the Nordic Cancer Union with a grant of 25000 EUROS The patients will be randomised to follow-up with CEA multislice CT scan of the liver and X-ray of the lungs either 12 and 36 months after surgery or 6 12 18 24 and 36 months after surgery If recurrence is detected the patient will be offered the best available treatment either as repeated surgery with curative intent or palliative oncological treatment Data will be collected electronically via the internet to an already constructed database The primary efficacy parameter is 3 and 5 years overall and cancer-specific survival It is planned that recruitment will be at least 2500 patients which is feasible in 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Danish Cancer Union 56 100 306 | None | None | None |