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
Protocol serial number	N/A
Sponsor	Region Östergötland
Funder	Linköping University Hospital

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Kristina Hasselgren
Scientific

Linköping University Hospital
Garnisonsvägen
Linköping
581 85
Sweden

ORCID ID	0000-0002-0792-1588
Phone	+46 (0)10 1030000
Email	Kristina.Hasselgren@liu.se

Study information

Primary study design	Observational
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)
Secondary study design	Cohort study
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Factors, beside surgery, that have an impact on prognosis and survival
Completion date	30/06/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Linköping University Hospital

Linköping
581 85
Sweden

Lund University Hospital

Lund
222 41
Sweden

Karolinska University Hospital

Stockholm
171 76
Sweden

Uppsala University Hospital

Uppsala
751 85
Sweden

Umeå University Hospital

Umeå
907 37
Sweden

Sahlgrenska University Hospital

Gothenburg
431 80
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.