Condition category
Cancer
Date applied
08/01/2011
Date assigned
18/02/2011
Last edited
25/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When cancer spreads from the part of the body where it started (the primary tumour) to other parts of the body, these tumours are called metastases. Some tumours can be removed (resected) by surgery but some cannot (unresectable). Currently it is unclear whether patients with colon cancer and unresectable metastases should have the primary tumour resected before undergoing chemotherapy. Surgery delays the start of chemotherapy and bears a risk of severe complications and death, but it may prolong survival. The aim of this study is to find out whether primary tumour resection before chemotherapy prolongs the survival of patients with colon cancer.

Who can participate?
Patients aged 18 or over, recently diagnosed with colon cancer with unresectable metastases.

What does the study involve?
Participants are randomly allocated to one of two groups. One group undergoes surgical resection of the primary tumour before undergoing chemotherapy. The other group undergoes chemotherapy without resection of the primary tumour. Participants’ survival is assessed with a minimum follow-up of 36 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospital Carl Gustav Carus Dresden (Germany)

When is the study starting and how long is it expected to run for?
September 2011 to December 2019

Who is funding the study?
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Who is the main contact?
Prof Jürgen Weitz
Direktor-VTG-Chirurgie@uniklinikum-dresden.de

Trial website

http://www.synchronous-trial.de

Contact information

Type

Scientific

Primary contact

Prof Jürgen Weitz

ORCID ID

Contact details

Department for Visceral
Thoracic and Vascular Surgery
University Hospital Carl Gustav Carus Dresden
Fetscherstr. 74
Dresden
01304
Germany
+49 (0)351/458 2742
Direktor-VTG-Chirurgie@uniklinikum-dresden.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): a randomised controlled multicentre trial

Acronym

SYNCHRONOUS

Study hypothesis

Hypothesis as of 25/07/2016:
Resection of the primary tumour prolongs survival from 15 to 21 months compared to systemic therapy without prior tumour resection.

Original hypothesis:
Resection of the primary tumour prolongs survival from 20 to 26 months compared to systemic therapy without prior tumour resection.

Ethics approval

Ethics approval was obtained from the Ethics Board of the Medical Faculty at the University of Heidelberg on 08/04/2011. Amendment 1 was voted positive on 26/06/2012. Amendment 2 was voted positive on 28/01/2015.

Study design

Prospective randomised controlled open multicentre trial with two parallel study groups

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Synchronous metastatic colon cancer not amenable for curative therapy

Intervention

Experimental arm: Surgical resection of the primary tumour prior to systemic therapy
Control arm: Systemic therapy without previous resection of the primary tumour

The duration of follow-up is 36 months for both arms.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Overall survival is measured by follow up visits every 6 months up to 36 months and documented by participating hospitals in the eCRF (QoL questionnaire, medical treatment record, laboratory values of tumour markers; in case of death additional information on date cause of death is required).

Secondary outcome measures

1. Time-to-development of primary tumour complications (control arm), assessed until the end of the trial
2. Kind of primary tumour complications (control arm), assessed until the end of the trial
3. Need for intervention due to primary tumour complication (control arm), assessed until the end of the trial
4. Peri-operative morbidity (experimental arm) at 30 days after surgery
5. Peri-operative mortality (experimental arm) at 30 days after surgery
6. Interventions with curative intent (experimental and control arm), assessed until the end of the trial
7. Quality of life (EORTC QLQ C30 and CR29) at three months and six months after randomisation and then every six months

Overall trial start date

31/01/2011

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed, histologically confirmed colon cancer and/or high rectal cancer
2. Synchronous metastases not amenable for curative therapy; assessment by a local tumour board at each trial centre consisting of a surgeon, a medical oncologist or gastroenterologist and a radiologist
3. Resectable primary tumour
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
5. Adequate medical condition to tolerate surgery and/or chemotherapy
6. Age greater than or equal to 18 years
7. Given informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

392

Participant exclusion criteria

1. Rectal cancer (tumor up to 12 cm from the anal verge)
2. Tumour-related symptoms requiring urgent surgery
3. Patients not eligible for surgery (American Society of Anaesthesiologists [ASA] greater than or equal to IV)
4. Unequivocal extensive peritoneal metastases, i.e., lower gastrointestinal bleeding requiring transfusion, bowel obstruction, tumour perforation or intractable pain at site of primary tumour
5. Chemotherapy or radiotherapy during the past 6 months
6. History of another primary cancer. Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer or other primary solid tumour curatively treated with no known active disease present and no treatment administered for greater than or equal to 5 years prior to randomisation.
7. Expected lack of compliance

Recruitment start date

01/09/2011

Recruitment end date

31/10/2016

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

University Hospital Carl Gustav Carus Dresden
Fetscherstraße 74
Dresden
01304
Germany

Sponsor information

Organisation

University Hospital Heidelberg

Sponsor details

c/o Irmtraut Gürkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
+49 6221 56 7002
irmtraut.guerkan@med.uni-heidelberg.de

Sponsor type

University/education

Website

http://www.uni-heidelberg.de

Funders

Funder type

Research council

Funder name

Deutsche Forschungsgemeinschaft

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Results and Publications

Publication and dissemination plan

Trial results will be published in a peer reviewed international journal, if possible with in a journal with a high impact factor.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22480173

Publication citations

  1. Protocol

    Rahbari NN, Lordick F, Fink C, Bork U, Stange A, Jäger D, Luntz SP, Englert S, Rossion I, Koch M, Büchler MW, Kieser M, Weitz J, , Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS--a randomised controlled multicentre trial (ISRCTN30964555)., BMC Cancer, 2012, 12, 142, doi: 10.1186/1471-2407-12-142.

Additional files

Editorial Notes

25/07/2016: The overall trial dates has been updated from 01/09/2011- 01/06/2016 to 31/01/2011 - 31/12/2019 and the recruitment end date has been updated from 01/06/2016 to 31/10/2016. In addition the target number of participants has been updated from 800 to 392 and the date of a second ethics approval amendment has been added. The inclusion criteria have been updated to include participants with colon cancer and/or high rectal cancer (previously only colon cancer) and the hypothesis has been updated. 17/03/2016: Plain English summary added. 03/09/2013: Austria was added to the countries of recruitment and the overall trial start date was changed from 01/05/2011 to 01/09/2011.