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OpenTrials
Completed

NCT Number: NCT02877368

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed tomography

Other

Primary outcomes

  1. sarcopenia

    Time frame: 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 outcomes

  1. Imatinib-induced toxicities

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: SARCO-GIST

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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