Condition category
Cancer
Date applied
08/01/2011
Date assigned
18/02/2011
Last edited
03/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

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
+49 351/458 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 Trial

Study hypothesis

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

On 03/09/2013, Austria was added to the countries of recruitment and the anticipated start date was changed from 01/05/2011 to 01/09/2011.

Ethics approval

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

Study design

Prospective randomised controlled open multicentre trial with two parallel study groups

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Overall survival

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

01/09/2011

Overall trial end date

01/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed, histologically confirmed colon 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

800

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

01/06/2016

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

Department for Visceral, Thoracic and Vascular Surgery
Dresden
01304
Germany

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

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

Sponsor type

University/education

Website

http://www.uni-heidelberg.de

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

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