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For Those Affected By Sarcomas!

Three versus five years of adjuvant imatinib as treatment of patients with operable GIST (SSG XXII)

Three years of imatinib (Gleevec, Glivec) is considered the standard duration of adjuvant (preventive) therapy for patients with operable GIST, but a high risk of relapse.
Yet, many patients are still at a high risk of GIST recurrence after completion of 3 years of adjuvant imatinib, and might benefit from further adjuvant imatinib therapy. The risk of GIST recurrence after 3 years of adjuvant imatinib can be estimated using prognostic factors, e.g. tumour mitotic count and tumour site. Patients with a high tumour mitotic count and GIST located at a nongastric site have the greatest risk.

 

Trial name SSG XXII: Three versus five years of adjuvant imatinib in patients with operable GIST
Agents

Imatinib

Phase III
Status  Open, recruiting
Sponsor

Scandinavian Sarcoma Group

 

Further information: https://www.clinicaltrials.gov/ct2/show/NCT02413736?term=adjuvant+imatinib&cond=GIST&rank=5

 

WHO is the trial for?

  • Patients treated with adjuvant imatinib for 3 years after complete surgical removal of high-risk GIST
  • Patients who are considered to be at a high risk of GIST recurrence despite 3 years of adjuvant imatinib
  • Overall health status of the patient has to be good (ECOG performance status 0-2)

Important: Patients with metastatic GIST or patients that had a relapse cannot take part in the study. Those patients usually receive imatinib lifelong or until disease progression.

WHAT is the key question that this trial is attempting to answer?

The study tries to answer the question if a prolonged adjuvant (preventive) therapy with imatinib for a total of 5 years will prevent some of the GISTs to recur as compared to patients who receive adjuvant imatinib for 3 years. It includes patients who have been diagnosed with GIST and have been treated with adjuvant imatinib for 3 years after surgery.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy and will further support the research in GIST and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

The study is open (recruiting)

WHERE is the trial available?

The trial is available in various study centers across Europe:

Sweden:

  • Skane University Hospital, Skane
  • Sahlgrenska University Hospital, Göteborg
  • Karolinska University Hospital, Solna
  • Linköping University Hospital, Linköping
  • Orebro University Hospital, Örebro
  • Norrland University Hospital, Umea

 

Finland:

  • Helsinki University Hospital, Helsinki
  • Turku University Hospital, Turku
  • Tampere University Hospital, Tampere
  • Oulu University Hospital, Oulu
  • Kuopio University Hospital, Kuopio
  • Satakunta Central Hospital Pori, Pori

 

Norway:

  • Oslo University Radium Hospital, Oslo
  • Haukeland University Hospital, Bergen
  • St Olav University Hospital, Trondheim
  • University Hospital of North Norway, Tromso

 

Denmark:

  • Copenhagen University Hospital, Copenhagen
  • Aarhus University Hospital, Aarhus

 

Spain:

  • Hospital La Paz, Madrid
  • Hospital Son Espases, Palma (Mallorca)
  • Hospital Vall d'Hebrón, Barcelona
  • Hospital Sant Pau, Barcelona
  • Hospital General De Valencia, Valencia
  • ICO Hospitalet, Barcelona
  • ICO Badalona, Barcelona
  • Hospital General Universitario Gregorio Marañón, Madrid
  • Instituto Valenciano de Oncología IVO, Valencia
  • Hospital Universitario Puerta de Hierro Majadahonda (HPH), Madrid
  • Hospital Universitario de Canarias, Santa Cruz de Tenerife
  • Hospital Virgen de la Macarena, Sevilla
  • Hospital Virgen del Rocío, Sevilla
  • Hospital Alvaro Cunqueiro, Vigo
  • Hospital Virgen de la Victoria, Malaga

 

UK:

  • Cambridge Clinical Trial Unit, Cambridge
  • Royal Marsden Hospital, London
  • Addenbrookes Hospital, Cambridge
  • University College London Hospital (UCLH), London
  • Beatson Hospital, Glasgow
  • Weston Park, Sheffield
  • Nottingham
  • Manchester
  • Birmingham

 

Germany:

  • Sarkom-Zentrum Berlin-Brandenburg, HELIOS Klinikum Berlin-Buch
  • Krankenhaus Nordwest, Frankfurt am Main
  • Sarkom-Zentrum am WTZ Westdeutschen Tumorzentrum, Universitätsklinikum Essen
  • Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Otto-von-Guericke-Universität, Magdeburg
  • MVZ Hämatologisch-Onkologische Praxis Altona (HOPA), Hamburg
  • Klinikum Großhadern, München
  • Medizinische Universitätsklinik, Abteilung II, Tübingen
  • Universitätsklinikum Würzburg, Klinik & Poliklinik für Allgemein- und Viszeralchirurgie, Gefäß- und Kinderchirurgie,

 

The Netherlands:

  • Leiden University Medical Centre, Leiden
  • NKI-AVL, Amsterdam
  • Radboudumc, Nijmegen
  • University Medical Centre Groningen, Groningen

 

Austria:

  • AKH Vienna, Vienna
  • LKH Wiener Neustadt
  • LKH Graz
  • Klinikum Wels-Grieskirchen, Wels

 

Study coordinator:

Scandinavian Sarcoma Group
Heikki Joensuu, MD,
Raija Husa,
Tel. 094711 ext 358

 

STUDY DESIGN: What does the study look like?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups.
One group will receive imatinib for 2 more years, the other group will stop imatinib. Both groups will be closely monitored (follow-up).

SPAEN Study Registry 3vs5yearsImatinib SSG

 

HOW do I get more information?

Patient organisations supporting GIST and/or sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

RESULTS of the study

No results are available at this time. Future results will be linked here.


Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

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