Patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index
Conditions
Interventions
Trade Name: Glivec
Product Name: Glivec
Pharmaceutical Form: Capsule
INN or Proposed INN: IMATINIB
CAS Number: 152459-95-5
Current Sponsor code: IMATINIB
Other descriptive name: IMATINIB
Sponsors
Assistance Publique Hôpitaux de MARSEILLE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject with no prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy - Subject with a Performance Status between 0-2 - Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces Institute of Pathology classification [Miettenen 2006] - Subject with Genomic Grade Index higher than 10 determined by CGH array; - Subject with surgery for primary tumor performed from 2 weeks to 2 months before starting adjuvant Imatinib mesylate; - Subject with no evidence of residual macroscopic disease after surgery (RO). Microscopically infiltrated margins, or supposed to be are allowed (R1) - Subjects with absence of distant metastases Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Subject under 18 years old or pregnant or breast-feeding women. - Subject with a contraindication to Imatinib, a known hypersensitivity to the active substance or to any of the excipients (ambivalence clause); - Subject treated with medicinal products that induce CYP3A4; - Subject who have experienced spontaneous tumor rupture before surgery (risk of spread); - Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor block; - Subject whose mutational status meets the wild phenotype definition as evidenced by sequencing from tumor block;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of adjuvant Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index.;Secondary Objective: The second objectives of this study are to compare the two therapeutic approaches in terms of: -Metastasis-free survival at 1 year, 2 years and 3 years -Overall survival -Clinical and biological tolerance, safety -Quality of life of patients and caregivers ;Primary end point(s): The primary criterion is the efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan. The rate of metastatic relapse at two years will be defined by the percentage of patients developing thoraco-abdominal and pelvic metastases on CT scan. Computed tomography scan with contrast (chest, abdomen and pelvis plus other areas as appropriate) will be used for assessment of metastasis. The same diagnosis method must be used throughout the study to evaluate diagnose a metastatic;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Secondary efficacy endpoints Efficacy will be complemented by 1-year, 2-year and 3-year metastasis-free survival based on a thoraco-abdominal and pelvic CT-scan using the same procedure as detailed below. Metastasis-free survival will be defined as the time from the baseline visit (feedback of the randomization to the patient) and the earliest date of documented radiological occurrence of metastasis. ? Overall survival Overall survival will be defined as the time from baseline evaluation (randomization) until death due to any cause (linked or not to the disease). ? Clinical and biological tolerance Safety and tolerance will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC) at 15 days, 1 month and every three months. The investigator will grade all adverse events and severe adverse events (defined by the standard medical dictionary for regulatory activities, MedDRA) according to the NCI-CTCAE (version 4.0). Adverse events will be grouped by system organ classes. ? Patients’ quality of life The quality of life of the subject will be assessed by means of 2 questionnaires: - A generic questionnaire: the French version of the SF36 [Leplège 1998]. This standardized questionnaire validated for the French population comprises 36 items that are used to calculate eight scale scores (physical functioning, social functioning, role–physical, role–emotional, mental health, vitality, bodily pain and general health). Two composite summary measures can also be calculated; the Physical Component Summary and the Mental Component Summary scores. SF36 yield scores on a 0–100 scale (0 = low QoL; 100 = high QoL). French reference values are available. - A specific questionnaire, the French version of the EORTC QLQ-C30. EORTC QLQ-C30, assesses the quality of life of cancer patients. It is a 30-item questionnaire comprised of five functional scales (physical, role, emotional, cognitive, | — |
Countries
France
Contacts
Public ContactDESALBRES Urielle
Assistance Publique Hôpitaux de MARSEILLE
Outcome results
None listed