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Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST

NCT05970900 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Stromal Tumor of Rectum

Interventions

DRUG

Imatinib Mesylate

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.

PROCEDURE

Local resection

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

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Principal Investigators

  • Weizhong Jiang, MD · Fujian Medical University Union Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-10-01
Completion
2029-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05970900 on ClinicalTrials.gov