AGITG clinical trials:  EORTC 62024

This is a study of intermediate and high-risk localised, completely resected, gastro-intestinal stromal tumours (GIST) expressing c-kit receptor. It is a controlled randomised trial on adjuvant imatinib mesylate (Glivec ®) versus no further therapy after completing surgery.

Imatinib mesylate is highly effective in advanced, unresectable GIST. However, the long-term effect of this agent on survival outcomes remains unclear. This study will compare the effect of adjuvant imatinib mesylate versus observation only on the prognosis of patients with completely resected localised gastrointestinal stromal tumours at intermediate- or high-risk of relapse.

Cancer type:   Gastrointestinal stromal tumour (GIST)
Trial status:  In follow-up
For more information: http://agitg.org.au/clinical-trials/trials-in-follow-up/


AGITG clinical trials:
 AG0102 GIST / EORTC 62005

This is a Phase III randomised, multi-centre, international trial to determine the relation between dose and clinical activity of tablet STI-571 (Glivec ®) in patients with a malignant gastrointestinal stromal tumour (GIST) that has spread or can’t be removed by a resection operation, and who express the c-kit receptor tyrosine kinase (CD117).

GIST is rare and highly resistant to standard chemotherapy and radiation. STI-571 has produced dramatic responses in people with this kind of cancer.

This trial is comparing higher and lower doses of the drug to see which works best. Trials of STI-571 in other cancers are being planned around the world.


Cancer type:  
Gastrointestinal stromal tumour (GIST)
Trial status:  In follow-up
For more information: http://agitg.org.au/clinical-trials/trials-in-follow-up/


AGITG clinical trials:
 ALT GIST

ALT GIST is a randomised phase II trial of imatinib alternating with  regorafenib, compared to imatinib alone, in first-line  treatment of advanced gastrointestinal stromal tumour (GIST).

ALT GIST was developed by the AGITG with the Scandinavian Sarcoma Group and is co-ordinated in Europe in collaboration with the European Organisation for Research and Treatment of Cancer. It will open ten Australian sites and recruit 30 Australian patients among 240 worldwide.

GIST cancers are rare, estimated to cause between 0.1% and 3% of GI cancer malignancies in Australia. Their incidence peaks among people in their fifties and sixties, the progress and symptoms of the illness varying widely.

The trial will assess best options for first-line treatment of advanced GIST — particularly whether an alternating regimen of the two drugs has sufficient activity and safety to warrant further evaluation as a first-line treatment for metastatic GIST.

Despite highly active treatment for metastatic GIST with the use of imatinib, most people will ultimately relapse and die of multifocal metastatic disease. Using an alternating regimen of imatinib and regorafenib with brief drug-free intervals may allow tumour stem cells to re-enter the cell cycle and become susceptible again to drug therapy.

Cancer type:   Gastrointestinal stromal tumour (GIST)
Trial status:  Open to patient participation
Eligibility:   The trial is seeking to recruit patients with metastatic GIST.
For more information: http://agitg.org.au/alt-gist-study/

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