SSG XVIII
Titel

Short (12 months) versus long (36 months) duration of adjuvant treatment with the tyrosine kinase inhibitor imatinib mesylate of operable GIST with a high risk for recurrence

Akronym SSG XVIII
Typ av studie

Randomized phase III multicenter study
Sponsor

Working Committee of the Scandinavian Sarcoma Group and the Sarcoma Group of the AIO.
Inklusionskriterier
  • Age >18 years
  • Histologically confirmed GIST, CD117 (KIT) positive
  • More than 50% risk of recurrence within the first 5 years after surgery (defined as tumor diameter >5.0 cm and mitotic count >5/50 HPFs; or tumor diameter >10.0 cm and any mitotic count; or tumor of any size with a mitotic count >10/50 HPFs; or tumor that ruptured into the peritoneal cavity)
  • ECOG performance status <2
  • Adequate organ function
Studiedesign rand

Imatinib 12 months

Imatinib 36 months
Endpoint(s) Event-free survival. (assessed by CT or MRI at 6 months intervals during the study)
Rekryteringsperiod 2003 12 –  2008 09
Antal inkluderade patienter 400
Publikationer

–
   
pil Tillbaka till Kliniska prövningar
Uppdaterad: 2008 09 30