Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-m… (NCT05970900) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST
China23 participantsStarted 2023-10-01
Plain-language summary
Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIST) underwent abdominoperineal resection (APR), a surgical procedure that involved the removal of the anus and necessitated a permanent colostomy.
This study aims to investigate the safety and viability of an organ-preserving approach involving preoperative imatinib mesylate treatment in conjunction with local resection for rectal GIST, specifically targeting patients with c-KIT gene mutations.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Over the age of 18.
✓. Newly pathology-diagnosed rectal GIST
✓. Tumor \> 2cm; local resection of R0 is not possible in the initial evaluation.
✓. The lower margin of the tumor is ≤ 5cm from the anal verge.
✓. C-KIT gene mutation.
✓. Male or non-pregnant female.
✓. ECOG score 0-2.
✓. Did not receive targeted therapy before the start of the clinical trial.
. The patient is not permitted to have additional primary malignant tumors within five years unless those tumors are currently deemed clinically insignificant and do not necessitate active intervention, such as basal cell skin cancer or cervical cancer in situ. The presence of any other malignant diseases is strictly prohibited.
✕. Individuals diagnosed with stage III or IV cardiac conditions, specifically congestive heart failure and myocardial infarction occurring within six months prior to the commencement of the study.
✕. The patient presents with severe and/or uncontrolled medical ailments, such as unmanaged diabetes, advanced chronic kidney disease, or active uncontrolled infection.
✕. Co-administration of imatinib with warfarin or acetaminophen is contraindicated, necessitating the substitution of alternative medications (e.g., low molecular weight heparin in place of warfarin).