IMATINIB MESILATE for Gastrointestinal stromal tumor

Inclusion criteria

• {"criterion_text":"- Man or woman 18 years old or over and Performance Status: 0-2\n- No prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy for the past 3 years\n- Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces Institute of Pathology classification [Miettenen 2006]\n- Subject with Genomic Grade Index higher than 10 determined by CGH array\n- Subject with surgery for primary tumor performed from 2 weeks to 3 months before starting adjuvant Imatinib mesylate\n- Subject with no evidence of residual macroscopic disease after surgery (RO). Microscopically infiltrated margins, or supposed to be are allowed (R1)\n- Subjects with absence of distant metastases"}

Exclusion criteria

• {"criterion_text":"- Subjects meeting any of the following criteria must not be enrolled\n- Minors or pregnant or breast-feeding women.\n- Subject with a contraindication to Imatinib, a known hypersensitivity to the active substance or to any of the excipients (ambivalence clause)\n- Subject treated with medicinal products that induce CYP3A4\n- Subject who have experienced spontaneous tumor rupture before surgery (risk of spread)\n- Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor block\n- Subject whose mutational status meets the wild phenotype definition as evidenced by sequencing from tumor block"}

Primary endpoints

• {"endpoint_text":"- The efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan","definition_or_measurement_approach":"Based on a thoraco-abdominal and pelvic CT-scan to assess the rate of metastatic relapse at 2 years."}

Secondary endpoints

• {"endpoint_text":"- 1-year, 2-year and 3-year metastasis-free survival based on a thoraco-abdominal and pelvic CT-scan. 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.","definition_or_measurement_approach":"Metastasis-free survival defined as time from baseline visit (feedback of randomization) to earliest date of documented radiological occurrence of metastasis; assessed by thoraco-abdominal and pelvic CT-scan."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Clinical and biological tolerance","definition_or_measurement_approach":""}
• {"endpoint_text":"- Patients’ quality of life assesssed by a generic questionnaire: the French version of the SF36 [Leplège 1998] and s specific questionnaire, the French version of the EORTC QLQ-C30. EORTC QLQ-C30","definition_or_measurement_approach":"Quality of life assessed using the French version of the SF-36 and the French version of the EORTC QLQ-C30."}

France

Earliest CTIS Part Ii Submission Date

15-07-2024

Latest Decision Or Authorization Date

26-07-2024

Processing Time Days

11

Number Of Sites

14

Number Of Participants

80

Primary sponsor

Full Name

Centre Hospitalier Regional De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France