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Trial Title:
Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST
NCT ID:
NCT05970900
Condition:
Gastrointestinal Stromal Tumor of Rectum
Conditions: Official terms:
Gastrointestinal Stromal Tumors
Imatinib Mesylate
Conditions: Keywords:
Gastrointestinal Stromal Tumor
Rectum
Imatinib mesylate
c-KIT gene
Local resection
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Imatinib Mesylate
Description:
1. For patients with c-KIT exon 11 mutation, imatinib mesylate, 400mg, qd.
2. For patients with c-KIT exon 9 mutation, imatinib mesylate, 600mg or 800mg, qd.
Arm group label:
Preoperative Imatinib + local excision
Other name:
Gleevec
Intervention type:
Procedure
Intervention name:
Local resection
Description:
According to the characteristics of the location of the tumor, the surgeon decides the
surgical approach based on the existing literature and the availability of surgical
equipment, including:
1. Local transanal resection (TA)
2. Local resection transsacralapproach
3. Local resection via perineal approach
4. Local resection transvaginal approach
Arm group label:
Preoperative Imatinib + local excision
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.
Detailed description:
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.
Previous studies have established that preoperative administration of imatinib mesylate
effectively diminishes the size of rectal gastrointestinal stromal tumors (GIST) and
enhances the likelihood of sphincter preservation. After initiating preoperative imatinib
mesylate treatment, the sphincter preservation rate has notably escalated from 4.2% to
33.0%-94.9%.
In theory, lymph node resection is not required for Gastrointestinal Stromal Tumors
(GIST); the local excision of rectal GIST enables sphincter preservation and yields
satisfactory anal function and quality of life (QoL). Various surgical techniques are
utilized for local excision, including traditional transanal (TA) and transanal minimally
invasive surgery (TAMIS) approaches.
This study aims to explore the safety and feasibility of an organ-preservation strategy
of preoperative imatinib mesylate combined with local resection in rectal
gastrointestinal stromal tumor (GIST), specifically for patients with c-KIT gene
mutations.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Over the age of 18.
2. Newly pathology-diagnosed rectal GIST
3. Tumor > 2cm; local resection of R0 is not possible in the initial evaluation.
4. The lower margin of the tumor is ≤ 5cm from the anal verge.
5. C-KIT gene mutation.
6. Male or non-pregnant female.
7. ECOG score 0-2.
8. Did not receive targeted therapy before the start of the clinical trial.
9. Sufficient organ functions are defined as follows:
Total bilirubin < 1.5×ULN (upper limit of normal, ULN), serum AST (SGOT) and ALT
(SGPT) < 2. 5 × ULN, creatinine < 1.5×ULN, neutrophil count > 1. 5 ×109 / L,
platelet > 100 × 109 / L.
10. The patient's informed consent has been obtained.
Exclusion Criteria:
1. Pathology is non-rectal GIST.
2. Under the age of 18.
3. Patients with distant metastasis.
4. 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.
5. 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.
6. The patient presents with severe and/or uncontrolled medical ailments, such as
unmanaged diabetes, advanced chronic kidney disease, or active uncontrolled
infection.
7. 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).
8. Subjects undergoing radiotherapy, chemotherapy, and/or targeted therapy.
9. Pregnant or lactating female patients.
10. Cognitive or psychiatric disorders.
11. Profound cardiac, hepatic, and renal dysfunction.
12. Non-adherence by the patient or the researchers' assessment of the patient's
inability to complete the entire trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Weizhong Jiang
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Start date:
October 1, 2023
Completion date:
October 1, 2029
Lead sponsor:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Source:
Fujian Medical University Union Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05970900
