Clinical trial NCT02877368: Sarcopenia in Patients With Gastrointestinal Stromal Tumours
Official title: Sarcopenia in Patients With Gastrointestinal Stromal Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumours
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) with imatinib prescribed at a fixed dose of 400 mg/day.

Brief summary: 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.

Detailed description: Aims of the study were:

* to assess the influence of imatinib on sarcopenia patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST)
* to compare imatinib-induced toxicities between patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) with pre-treatment sarcopenia and patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) without pre-treatment sarcopenia

Eligibility criteria: 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

Primary outcomes:
measure: sarcopenia
timeFrame: Day 0
Secondary outcomes:
measure: Imatinib-induced toxicities
timeFrame: Month 3
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
citation: Moryoussef F, Dhooge M, Volet J, Barbe C, Brezault C, Hoeffel C, Coriat R, Bouche 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.