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Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index
EU CTIS ID: 2024-515432-71-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Man or woman 18 years old or over and Performance Status: 0-2
- No prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy for the past 3 years
- 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 3 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)
You likely can't join if
- Subjects meeting any of the following criteria must not be enrolled
- Minors 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
See the full eligibility criteria
- Man or woman 18 years old or over and Performance Status: 0-2
- No prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy for the past 3 years
- 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 3 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
- Subjects meeting any of the following criteria must not be enrolled
- Minors 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.