The REGISTER Study: A multicentre phase II study of risk evaluation in gastrointestinal stromal tumours (GIST) with selective therapy escalation for response
The REGISTER Study: A multicentre phase II study of risk evaluation in gastrointestinal stromal tumours (GIST) with selective therapy escalation for response including treatment with imatinib (400 - 800mg/day) followed by nilotinib (800mg/day)
AGITG
80 participants
Dec 9, 2008
Interventional
Conditions
Summary
The REGISTER study aims to maximise the treatment potential of Glivec (Registered trade mark) (also known as imatinib) in patients with metastatic or unresectable Gastro-intestinal Stromal Tumour (GIST) by individualising treatment. Treatment for each patient will be determined according to the biological features of their tumour when examined in the laboratory. We know that tumours with certain findings are less likely to do well on standard treatment. Patients with these types of tumours will be treated with an increased dose of Glivec (Registered trade mark). Patients with tumours that we know are more likely to do well will be treated with a standard dose of Glivec (Registered trade mark) but will move on to an increased dose when the standard dose stops being effective. The response to treatment will be measured using Computerized axial Tomography (CT) scans. Early response will be measured using Fluorodeoxyglucose Positron Emission Tomography (FDG PET) scans.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Patient treatment regimen will be determined by KIT mutational status. For patients recieving less than or equal to 6 weeks of Imatinib will be classified as either exon 9/WT or exon 11. Patients will initially receive 400mg/day of imatinib (also known as Glivec) administered orally in tablet form. Patients will then receive an escalated dose up to 800mg/day imatinib. The timing of dose escalation will depend on the patient KIT mutational status (exon 9/WT or exon 11) and their early response to treatment. For patients who have received more than 6 weeks of imatinib they will continue on at a dose of 400mg/day until RECIST-defined progression where the dose will be escalated up to 800mg/day depending on the patient's response to treatment. The rest of the regime will be the same as patients who have received less than or equal to 6 weeks of imatinib treatment.
Locations(14)
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ACTRN12608000392369