Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00225641
Other study ID # COLOFOL
Secondary ID Danish Cancer Un
Status Active, not recruiting
Phase N/A
First received September 22, 2005
Last updated December 21, 2015
Start date March 2006
Est. completion date December 2015

Study information

Verified date December 2015
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Swedish National Council on Medical EthicsPoland: Ministry of Science and Higher Education
Study type Interventional

Clinical Trial 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 and/or for psychological reasons and/or 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.


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 25,000 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 2,500 patients, which is feasible in 2 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2500
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Radical surgery (R0-resection) for colorectal adenocarcinoma - with or without adjuvant treatment

- Age < 75 years

- Provision of written informed consent for participation

- "Clean colon" verified by perioperative barium enema or colonoscopy last 3 months post-surgery

- Tumour stage: II-III (Tany N1-2 M0, T3-4NanyM0, DukesĀ“ B - C)

Exclusion Criteria:

- A clinical diagnosis of HNPCC (non hereditary polyposis colorectal cancer) or FAP (familial polyposis coli)

- Local resection for colorectal cancer (e.g., TEM-procedure)

- Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis)

- Inability to provide informed consent or refusal to do so

- Inability to comply with the control or intense follow-up program

- Participation in other clinical trials interfering with the control-programs

- Previous malignancies (except for non-melanoma skin cancer)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
CT-scan, CEA, X-ray of lungs
Arm 1: 6, 12, 18, 24 and 36 months after surgery
CT-scan, CEA, X-ray of lungs
Arm 2: 12 and 36 months after surgery

Locations

Country Name City State
Denmark Peer Wille-Jørgensen Copenhagen

Sponsors (4)

Lead Sponsor Collaborator
Bispebjerg Hospital Danish Cancer Society, Danish Colorectal Cancer Group, Nordic Cancer Union

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall and cancer-specific mortality 5 years
Secondary Quality of life. Cost-effectiveness of follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A

External Links