Condition category
Cancer
Date applied
29/11/2017
Date assigned
22/01/2018
Last edited
19/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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 2018

Who is funding the study?
Linköping University Hospital

Who is the main contact?
Dr Kristina Hasselgren
Kristina.Hasselgren@liu.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kristina Hasselgren

ORCID ID

http://orcid.org/0000-0002-0792-1588

Contact details

Linköping University Hospital
Garnisonsvägen
Linköping
581 85
Sweden
+46 (0)10 1030000
Kristina.Hasselgren@liu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Factors impacting on prognosis and treatment in patients with liver and lung metastases from colorectal cancer - a Swedish national study

Acronym

Study hypothesis

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

The Regional Ethical Review Board in Linköping, 09/20/2017, ref 2017/363-31

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2017

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with liver and lung metastases from colorectal cancer

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Other diagnoses than colorectal cancer

Recruitment start date

01/01/2008

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköping University Hospital
Linköping
581 85
Sweden

Trial participating centre

Lund University Hospital
Lund
222 41
Sweden

Trial participating centre

Karolinska University Hospital
Stockholm
171 76
Sweden

Trial participating centre

Uppsala University Hospital
Uppsala
751 85
Sweden

Trial participating centre

Umeå University Hospital
Umeå
907 37
Sweden

Trial participating centre

Sahlgrenska University Hospital
Gothenburg
431 80
Sweden

Sponsor information

Organisation

Region Östergötland

Sponsor details

Linköping University Hospital
Garnisonsvägen
Linköping
581 85
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Linköping University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IP sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Per Sandström (per.sandstom@liu.se).

Intention to publish date

31/01/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes