Clinical trial · Observational
Sarcopenia in Patients With Gastrointestinal Stromal Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumours | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed tomography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- gastrointestinal stromal tumours
- description
- Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) .
- interventionNames
- Other: Computed tomography
Primary outcomes (1)
- measure
- sarcopenia
- timeFrame
- Day 0
- description
- 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.
Secondary outcomes (1)
- measure
- Imatinib-induced toxicities
- timeFrame
- Month 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDMoryoussef 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. PMID 26673372