Sarcopenia in Patients With Gastrointestinal Stromal Tumours

Completed

• Conditions: Gastrointestinal Stromal Tumours
• Interventions: Other: Computed tomography

• Registration Number: NCT02877368
• Lead Sponsor: CHU de Reims

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

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-24
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gastrointestinal stromal tumours	Computed tomography	Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) .

Primary Outcome Measures

Name	Time	Method
sarcopenia	Day 0	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 Outcome Measures

Name	Time	Method
Imatinib-induced toxicities	Month 3	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

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France