Spots Global Cancer Trial Database for The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer
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Trial Identification
Brief Title: The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer
Official Title: The Role of Surgery of the Primary Tumour With Few or Absent Symptoms in Patients With Synchronous Unresectable Metastases of Colorectal Cancer, a Randomized Phase III Study. A Study of the Dutch Colorectal Cancer Group (DCCG)
Study ID: NCT01606098
Study Description
Brief Summary: The clinical benefit of resection of the primary tumour in patients with synchronous unresectable metastases is not known. In the literature studies usually describe retrospective selected patients with synchronous metastases treated with or without resection of the primary tumour. All these studies are biased in patient selection and there are no prospective randomized studies on this topic. In patients with few or absent symptoms of the primary tumour, arguments both in favour and against initial resection have been presented, and therefore a randomized trial is warranted. Although recent publications suggest that resection of the primary tumour in synchronous metastasized colon cancer patients might not be necessary, this appears to be based on feasibility and not on clinical outcome. Several studies comparing large groups of patients with or without resection of the primary tumour suggest an improved survival when the primary tumour is resected. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour during chemotherapy treatment or during later stages of the disease. A recent analysis of the CAIRO and CAIRO2 data showed that metastatic colon cancer patients who had a resection of the primary tumour prior to study entry, had an improved survival compared to patients without a resection of the primary tumour. However, these patients were selected after the primary tumour was resected and therefore these results are not corrected for surgical morbidity and mortality. The investigators here propose a randomized trial in order to demonstrate that resection of the primary tumour does improve overall survival.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital Aalborg, Aalborg, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Herlev Hospital, Herlev, , Denmark
Regionshospital Herning, Herning, , Denmark
Roskilde hospital, Roskilde, , Denmark
Medisch Centrum Alkmaar, Alkmaar, , Netherlands
Ziekenhuisgroep Twente, Almelo, , Netherlands
Flevoziekenhuis, Almere, , Netherlands
Ziekenhuis Amstelland, Amstelveen, , Netherlands
Academic Medical Centre, Amsterdam, , Netherlands
OLVG, Amsterdam, , Netherlands
VUMC, Amsterdam, , Netherlands
Gelre Ziekenhuis, Apeldoorn, , Netherlands
Wilhelmina Ziekenhuis, Assen, , Netherlands
Rode Kruis Ziekenhuis, Beverwijk, , Netherlands
Amphia Ziekenhuis, Breda, , Netherlands
Jeroen Bosch, Den Bosch, , Netherlands
MC Haaglanden en Bronovo Nebo, Den Haag, , Netherlands
Slingeland Ziekenhuis, Doetinchem, , Netherlands
Albert Schweitzer Ziekenhuis, Dordrecht, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Maxima Medisch Centrum, Eindhoven, , Netherlands
St Annaziekenhuis, Geldrop, , Netherlands
Groene Hart Ziekenhuis, Gouda, , Netherlands
Martini Ziekenhuis, Groningen, , Netherlands
UMCG, Groningen, , Netherlands
Spaarne Gasthuis, Haarlem, , Netherlands
St Jansdal, Harderwijk, , Netherlands
Elkerliek Ziekenhuis, Helmond, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
St Antonius Ziekenhuis, Nieuwegein, , Netherlands
Radboudumc, Nijmegen, , Netherlands
Waterland Ziekenhuis, Purmerend, , Netherlands
Laurentius Ziekenhuis, Roermond, , Netherlands
Maasstad Ziekenhuis, Rotterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Fransicus Gastuis & Vlietland, Rotterdam, , Netherlands
Antonius Ziekenhuis, Sneek, , Netherlands
Ziekenhuis Rivierenland, Tiel, , Netherlands
Elisabeth-Tweesteden, Tilburg, , Netherlands
Bernhoven Ziekenhuis, Uden, , Netherlands
University Medical Centre Utrecht, Utrecht, , Netherlands
Bernhoven Ziekenhuis, Veghel, , Netherlands
VieCuri Medisch Centrum, Venlo, , Netherlands
Zaans Medisch Centrum, Zaandam, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Contact Details
Name: M. Koopman, Prof MD PhD
Affiliation: UMC Utrecht
Role: PRINCIPAL_INVESTIGATOR
Name: H. JW de Wilt, Prof MD PhD
Affiliation: Radboud University Medical Center
Role: PRINCIPAL_INVESTIGATOR
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