Factors impacting on prognosis and treatment in patients with liver and lung metastases from colorectal cancer
| ISRCTN | ISRCTN95689791 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95689791 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/11/2017
- Registration date
- 22/01/2018
- Last edited
- 14/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Colorectal cancer means cancer that starts in the colon (large bowel) or back passage (rectum). It is a common cancer, and in about half of patients it will spread to the liver (liver metastases). For patients with liver metastases the only treatment with long-term survival is surgery. It is however less well studied as to how many of those patients will also develop lung metastases, and above all which treatment will be the most beneficial. The aim of this study is to find out whether lung surgery improves survival, compared to chemotherapy, for patients with liver and lung metastases from colorectal cancer.
Who can participate?
All patients with liver and lung metastases from colorectal cancer
What does the study involve?
Data is gathered from the Swedish Colorectal Cancer Registry from 2007 to 2016, from the Swedish Liver Registry from 2008 to 2016 and from the Swedish Thoracic Registry from 2009 to 2016. Data is also gathered from the In Patients Registry and from the Death Registry from 2007 to 2016. The study period is from 2007 to 2016. From these registries all patients with liver and lung metastases from colorectal cancer are identified. The main study questions is whether there is any difference in survival depending on the type of treatment for liver and lung metastases and if there is any factor that may affect survival. The aim is to find out whether liver and lung surgery for patients with colorectal cancer results in an improved survival compared to liver surgery and palliative chemotherapy for lung metastases.
What are the possible benefits and risks of participating?
There are no benefits or risks for participants as the study only uses data gathered from registries.
Where is the study run from?
1. Linköping University Hospital (Sweden)
2. Lund University Hospital (Sweden)
3. Karolinska University Hospital (Sweden)
4. Uppsala University Hospital (Sweden)
5. Umeå University Hospital (Sweden)
6. Sahlgrenska University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
June 2017 to June 2020
Who is funding the study?
Linköping University Hospital
Who is the main contact?
Dr Kristina Hasselgren
Kristina.Hasselgren@liu.se
Contact information
Scientific
Linköping University Hospital
Garnisonsvägen
Linköping
581 85
Sweden
 ORCID ID |
0000-0002-0792-1588 |
|---|---|
| Phone | +46 (0)10 1030000 |
| Kristina.Hasselgren@liu.se |
Study information
| Study design | The study is a national registry study based on data from the Swedish Colorectal Cancer Registry (SCRCR), The Swedish Liver Registry (Sweliv) and The Swedish Thoracic Registry (ThoR) |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Factors impacting on prognosis and treatment in patients with liver and lung metastases from colorectal cancer - a Swedish national study |
| Study objectives | The aim of the study is to evaluate whether patients with liver and lung metastases from colorectal cancer have an improved survival if the are treated with liver and lung surgery compared to liver surgery and palliative chemotherapy for lung metastases. |
| Ethics approval(s) | The Regional Ethical Review Board in Linköping, 09/20/2017, ref 2017/363-31 |
| Health condition(s) or problem(s) studied | Patients with liver and lung metastases from colorectal cancer |
| Intervention | Data will be gathered from the Swedish Colorectal Cancer Registry from 2007 to 2016, from the Swedish Liver Registry from 2008 to 2016 and from the Swedish Thoracic Registry from 2009 to 2016. Data will also be gathered from the In Patients Registry and from the Death Registry from 2007 to 2016. The study period will be from 2007 to 2016. From these registries all patients with liver- and lung metastases from colorectal cancer will be identified. The main study questions is whether there is any difference in survival depending on treatment of liver- and lung metastases (resection, ablation, stereotactic body radiation therapy or chemotherapy) and if there is any prognostic factor that may affect the survival. The primary aim is to study whether liver and lung surgery for patients with colorectal cancer results in an improved survival compared to liver surgery and palliative chemotherapy for lung metastases. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Survival estimated from time of the diagnosis of the primary tumor, and for patients with metachronous liver metastases from the diagnosis of the liver metastases |
| Secondary outcome measures | Factors, beside surgery, that have an impact on prognosis and survival |
| Overall study start date | 01/06/2017 |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | All patients with liver and lung metastases from colorectal cancer |
| Key exclusion criteria | Other diagnoses than colorectal cancer |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Sweden
Study participating centres
581 85
Sweden
222 41
Sweden
171 76
Sweden
751 85
Sweden
907 37
Sweden
431 80
Sweden
Sponsor information
Hospital/treatment centre
Linköping University Hospital
Garnisonsvägen
Linköping
581 85
Sweden
"ROR" |
https://ror.org/0326gsy75 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Per Sandström (per.sandstom@liu.se). |
Editorial Notes
14/06/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2018 to 30/06/2020.
2. The intention to publish date was changed from 31/01/2019 to 30/06/2021.
