Ameloblastoma is the most common benign odontogenic tumor, characterized by high local invasiveness and a high recurrence rate. Currently, surgical treatment is the standard treatment modality. The main surgical approaches include radical resection represented by local extended resection (with a safety margin of more than 2 cm) and conservative procedures represented by curettage and fenestration. Although radical resection can effectively treat the disease, it often leads to severe jaw bone defects and even disrupts the continuity of the jaw bone. However, the conservative procedures have a recurrence rate of approximately 40%. This study aims to reduce the recurrence rate of conservative procedures by using neoadjuvant therapy with dabrafenib combined with trametinib, and to reduce surgical trauma while improving the radical cure effect. The endpoints of this study are the 3-year and 5-year recurrence rates, as well as the effectiveness and safety of the neoadjuvant therapy.
The primary endpoints are the 3-year and 5-year recurrence - free survival rates after neoadjuvant therapy followed by curettage and fenestration surgery. The secondary endpoints are the radiological response, pathological response, and safety of the neoadjuvant therapy with dabrafenib combined with trametinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
This clinical study investigates the combination of Dabrafenib (2 mg once daily for adults; 0.025 mg/kg/day for children ≥12 years, orally once daily) and Trametinib (2 mg once daily for adults; 0.025 mg/kg/day for children ≥12 years, orally once daily) as a treatment for \[specific condition\]. The treatment will be administered until disease progression or intolerable toxicities occur. Both medications should be taken at least 1 hour before or 2 hours after a meal, at the same time each day. If a dose is missed, it should be taken within 12 hours of the scheduled time. If less than 12 hours remain before the next dose, the missed dose should not be taken. Both medications should be taken in combination with the scheduled dose of Dabrafenib at either morning or evening and must not be chewed or crushed. Each treatment cycle lasts 30 days. At the end of each cycle, follow-up assessments will include clinical examination, laboratory tests to evaluate drug safety, and imaging studies to a
Recurrence - free survival rates
To evaluate the recurrence-free survival after neoadjuvant therapy with dabrafenib and trametinib, followed by curettage and fenestration surgery.
Time frame: Up to 5 years
Radiological response
The radiological response to neoadjuvant therapy with Dabrafenib and Trametinib in patients with ameloblastoma will be assessed through three-dimensional volumetric imaging (e.g., CT scans with 3D reconstruction) at predefined intervals. Tumor volume changes, as determined by 3D reconstruction, will be used to evaluate the radiological response.
Time frame: 3 months
Pathological response
The pathological response to neoadjuvant therapy with Dabrafenib and Trametinib in patients with ameloblastoma will be assessed through post-treatment surgical specimens.
Time frame: 4 months
AEs will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The safety of neoadjuvant therapy with Dabrafenib and Trametinib in patients with ameloblastoma will be assessed through monitoring adverse events (AEs). AEs will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, and graded based on severity (Grade 1 to Grade 5) and their relationship to the study drugs.
Time frame: 1 year
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