Sarcopenia in Patients With Gastrointestinal Stromal Tumours

NCT02877368 | Completed

• 1 other identifier: 2015Ao003
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumours

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Imatinib-induced toxicities

  Month 3

Study Arms (1)

gastrointestinal stromal tumours

Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) .

Other: Computed tomography

Interventions

Computed tomography OTHER

gastrointestinal stromal tumours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who did not have CT imaging within the 30 days preceding treatment onset

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (1)

• 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.

  PMID: 26673372 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

FR (1)