Neoadjuvant Therapy With Conservative Surgery vs. Up-front Conservative Surgery for BRAF V600E-Mutated Ameloblastoma

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ID
NCT06819605
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Ameloblastoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib and trametinib (combination) — DRUG
    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

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Feb 2025
Primary completion
Oct 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control group
    Curettage and fenestration surgery alone
  • Experimental: Neoadjuvant group
    Neoadjuvant therapy chemotherapy before curettage and fenestration surgery

Primary Outcome Measure

Recurrence - free survival rates [ Time Frame: Up to 5 years ]

Central Contacts