Support Centre
30 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Influence of primary tumour resection on the course of disease in patients with metastatic colon cancer and unresectable metastases
DOI 10.1186/ISRCTN30964555
ClinicalTrials.gov identifier
EudraCT number
Public title Influence of primary tumour resection on the course of disease in patients with metastatic colon cancer and unresectable metastases
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
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Austria, Germany
Disease/condition/study domain Synchronous metastatic colon cancer not amenable for curative therapy
Participants - 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
Participants - 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
Anticipated start date 01/09/2011
Anticipated end date 01/06/2016
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 800
Interventions 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.
Primary outcome measure(s) Overall survival
Secondary outcome measure(s) 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
Sources of funding German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Trial website http://www.synchronous-trial.de
Publications 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22480173
Contact name Prof  Jürgen  Weitz
  Address Department for Visceral, Thoracic and Vascular Surgery
University Hospital Carl Gustav Carus Dresden
Fetscherstr. 74
  City/town Dresden
  Zip/Postcode 01304
  Country Germany
  Tel +49 351/458 2742
  Email Direktor-VTG-Chirurgie@uniklinikum-dresden.de
Sponsor University of Heidelberg (Germany)
  Address c/o Irmtraut Gürkan
Im Neuenheimer Feld 672
  City/town Heidelberg
  Zip/Postcode 69120
  Country Germany
  Email irmtraut.guerkan@med.uni-heidelberg.de
  Sponsor website: http://www.uni-heidelberg.de
Date applied 08/01/2011
Last edited 03/09/2013
Date ISRCTN assigned 18/02/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.