Colon CancerNCT00963352
Colon Cancer Prognosis After Radical Surgery
An observational study of Colon Cancer, run by Haraldsplass Deaconess Hospital at 2 sites in Norway.
Trial summary
1. Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate measure of achievement of radical surgery is the number of lymph nodes removed with the specimen. 2. Markers. There may be variables that may make patient assessment more sound. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer
- How many people
- 300 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community patient population from hospital catchment area.
Who may be able to join
- Malignant tumor (adenocarcinoma) of the large intestine (colon)
- Willingness to participate
Who cannot join
- No radical resection (R0) possible
- Unwilling to participate or medically unfit to undergo follow-up
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Haraldsplass Deaconal Hospital, Department of Surgery
Bergen, 5009
Karl Sondenaa, MD, PhD, +47-91868877, kasoende@online.no
Kristian E. Storli, MD, +47-55978665, kstoris@hotmail.com
- Recruiting
Haukeland University Hospital
Bergen, 5021
Rune Haaverstad, MD, PhD, rune.haaverstad@helse-bergen.no
Bjarte Hjelmeland, MD
About this study
Official title: Prognosis of Colon Cancer. Clinical and Pathological-anatomical Factors Concerned With Radical Surgery
- Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate measure of achievement of radical surgery is the number of lymph nodes removed with the specimen.
- Markers. There may be variables that may make patient assessment more sound. The project is including investigation of such markers (genes, old age, comorbidity, and others).
- Laparoscopic resections. This is being used more and more in cancer surgery but the feasibility of this approach remains to be proven compared with conventional open surgery. The project compares these according to 1) and 2).
- Morbidity and mortality must be surveilled to keep at a minimum. Many patients have comorbidity and are old to make this factor extra important, including perioperative care.
- Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will be studied in particular.
Read the detailed description
- Radical surgery. A detailed description of procedures for each location of tumor in the large intestine is used. By following a given procedure for each location in the large intestine, the number of lymph nodes can be analyzed for each location to find out if this differs and if prognosis is affected by lymph node numbers according to tumor site.
- Markers. Different variables are examined for use in clinical judgment to make treatment better as well as genetic experimental analyses for comparison with clinical outcome to better understanding of clinical behavior.
- Laparoscopic resections. The technical challenge of laparoscopic approach has been compared with conventional surgery without any difference being observed in trials. However, it should be compared with radical open surgery to compare best achievements by using number of lymph nodes as well as outcome measures in the short and long term (mortality).
- Comorbidity, old age itself, type of surgery and perioperative care according to the so called fast track surgery may all play a part in reducing perioperative morbidity and mortality. A maximum 3% mortality should be aimed for.
- Colon cancer usually metastasize to the liver and lungs. Surgical treatment of liver metastases has been extensively studied and the prognosis has improved. Lung metastases has not been given similar attention but the prognosis of those operated may be good and equal that after liver surgery. The need for pulmonary resection and factors associated with metastases and lung metastases in particular will be studied.
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, Open surgery resection, Laparoscopic surgery resection, Morbidity, Mortality, Metastases, Oncology, Freedom of malignant disease recurrence, Safety of intervention open and laparoscopic, Examination of adverse markers, Development of metastases in lungs and other organs
- Medical subject headings
- Colonic Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated for colon cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival (DFS)
Measured: 2007/10 - 2010/13
Secondary outcomes (1)
5-year overall survival (OS)
Measured: 2007/10 - 2012/15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionAug 2009
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Karl Sondenaa, MD, PhD, Study chair, Haraldsplass Deaconal Hospital, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963352
- Sponsor's protocol ID
- Knut2009
- Status last verified
- Aug 2010
- First submitted
- 19 Aug 2009
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Colon Cancer. Clinical and Pathological-anatomical Factors Concerned With Radical Surgery
- ClinicalTrials.gov ID
- NCT00963352
- Acronym / sponsor ID
- Knut2009
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, Open surgery resection, Laparoscopic surgery resection, Morbidity, Mortality, Metastases, Oncology, Freedom of malignant disease recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate measure of achievement of radical surgery is the number of lymph nodes removed with the specimen.
- Markers. There may be variables that may make patient assessment more sound. The project is including investigation of such markers (genes, old age, comorbidity, and others).
- Laparoscopic resections. This is being used more and more in cancer surgery but the feasibility of this approach remains to be proven compared with conventional open surgery. The project compares these according to 1) and 2).
- Morbidity and mortality must be surveilled to keep at a minimum. Many patients have comorbidity and are old to make this factor extra important, including perioperative care.
- Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will be studied in particular.
Detailed description
- Radical surgery. A detailed description of procedures for each location of tumor in the large intestine is used. By following a given procedure for each location in the large intestine, the number of lymph nodes can be analyzed for each location to find out if this differs and if prognosis is affected by lymph node numbers according to tumor site.
- Markers. Different variables are examined for use in clinical judgment to make treatment better as well as genetic experimental analyses for comparison with clinical outcome to better understanding of clinical behavior.
- Laparoscopic resections. The technical challenge of laparoscopic approach has been compared with conventional surgery without any difference being observed in trials. However, it should be compared with radical open surgery to compare best achievements by using number of lymph nodes as well as outcome measures in the short and long term (mortality).
- Comorbidity, old age itself, type of surgery and perioperative care according to the so called fast track surgery may all play a part in reducing perioperative morbidity and mortality. A maximum 3% mortality should be aimed for.
- Colon cancer usually metastasize to the liver and lungs. Surgical treatment of liver metastases has been extensively studied and the prognosis has improved. Lung metastases has not been given similar attention but the prognosis of those operated may be good and equal that after liver surgery. The need for pulmonary resection and factors associated with metastases and lung metastases in particular will be studied.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated for colon cancer | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community patient population from hospital catchment area.
Key inclusion criteria (2 listed)
- Malignant tumor (adenocarcinoma) of the large intestine (colon)
- Willingness to participate
Key exclusion criteria (2 listed)
- No radical resection (R0) possible
- Unwilling to participate or medically unfit to undergo follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-year disease free survival (DFS)
Time frame: 2007/10 - 2010/13
1 secondary outcome
5-year overall survival (OS)
Time frame: 2007/10 - 2012/15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Sondenaa, MD, PhD study chair
Haraldsplass Deaconal Hospital, University of Bergen, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Haraldsplass Deaconess Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Sondenaa, MD, PhD (+47-91868877, kasoende@online.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival (DFS) (time frame: 2007/10 - 2010/13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.