Gastrointestinal Stromal Tumours Clinical Trial
— SARCO-GISTOfficial title:
Sarcopenia in Patients With Gastrointestinal Stromal Tumours
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) - Patients treated with imatinib prescribed at a fixed dose of 400 mg/day from 1 January 2005 to 31 December 2013 - Aged > 18 years Exclusion Criteria: - Patients who did not have CT imaging within the 30 days preceding treatment onset |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| France | Chu de Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
Moryoussef F, Dhooge M, Volet J, Barbe C, Brezault C, Hoeffel C, Coriat R, Bouché O. Reversible sarcopenia in patients with gastrointestinal stromal tumor treated with imatinib. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):343-50. doi: 10.1002/jcsm.12047. Epub 2015 Jun 4. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Day 0 | No |
| Secondary | 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 | Month 3 | No |