An observational study in Gastrointestinal Stromal Tumours, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-24.
Sponsored by CHU de Reims · Observational
The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor. Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is generally well-tolerated and known to improve performance status but up to 16% grades 3-4 toxicities, leading to at least 40% withdrawals, have been reported.
Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients included in phase 1 trials, suggesting that it should be considered an inclusion criterion for such studies. Sarcopenic patients had low performance status, shorter survival, more chemotherapy toxicities and post-operative infections, and longer post-operative hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib or sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal cell or hepatocellular carcinomas.
Computed tomography (CT) scans acquired during routine care have been validated as an accurate and robust imaging technique to evaluate sarcopenia in cancer patients.
Aims of the study were:
333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
This study's enrollment of 31 is below the median of 116 across 68 observational studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) with imatinib prescribed at a fixed dose of 400 mg/day.
Exclusion Criteria:
Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) .
Other: Computed tomography
sarcopenia
Sarcopenia was defined for men by lumbar skeletal muscle index \<53 cm2/m2 with body mass index \>25 kg/m2 and \<43 cm2/m2 with body mass index \<25 kg/m2 Sarcopenia was defined for women, by lumbar skeletal muscle index \<41 cm2/m2 with any body mass index.
Time frame: Day 0
Imatinib-induced toxicities
Toxicity regarding all site (cutaneous with edema, rash, pruritus, xerosis, digestif with nausea, diarrhea, vomiting, biology with anemia, neutropenia, hepatitis,general with asthenia, muscle cramps musculaires, arthralgia), graded according to the National Cancer Institute Common Toxicity Criteria, version 3.0
Time frame: Month 3
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Gastrointestinal Stromal Tumors→
CHU de Reims