Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653517
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant BRAFV600E-Targeted Therapy for Conventional Ameloblastoma of the JawA Single-Arm Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NETCAM
Brief Summary:
This study aims to evaluate the tumor shrinkage effect of preoperative targeted induction therapy with dabrafenib and trametinib in patients with conventional ameloblastoma harboring the BRAF V600E mutation The study will assess the proportion of cases where mandibular continuity cannot be preserved that can be converted to cases where mandibular continuity is preserved as well as the proportion of cases where complete resection is initially not feasible that become resectable
Detailed Description:
PRIMARY OBJECTIVES
Ⅰ To observe the proportion of patients with ameloblastoma requiring mandibular segmental resection at initial diagnosis who can convert to mandibular preservation surgery after preoperative induction therapy with dabrafenib and trametinib
ⅡTo observe the proportion of cases initially deemed non-radical resectable Surgery that become resectable
SECONDARY OBJECTIVES
Ⅰ Radiological response Ⅱ Pathological response Ⅲ Local recurrence-free survivalLRFS ⅣFeasibility and safety in this patient population
OUTLINE
Dabrafenib
Dosage 150 mg twice daily total daily dose of 300 mg Administration Must be taken in combination with trametinib until disease progression or intolerable toxicity occurs Administer at least 1 hour before or 2 hours after a meal with approximately 12 hours between doses Take at the same time each day If a dose is missed and less than 6 hours remain until the next dose the missed dose should not be taken When used in combination with trametinib take trametinib once daily at the same time as the morning or evening dose of dabrafenib Do not open crush or break the capsules
Trametinib
Dosage 2 mg once daily orally in combination with dabrafenib until disease progression or intolerable toxicity occurs
Administration Administer at least 1 hour before or 2 hours after a meal Take at the same time each day If a dose is missed it should be taken no later than 12 hours before the next scheduled dose If less than 12 hours remain until the next dose the missed dose should not be taken When used in combination with dabrafenib take trametinib once daily at the same time as the morning or evening dose of dabrafenib Do not chew or crush the tablets
Treatment Cycle
Cycle Length Each cycle lasts 30 days Initial Follow-Up Follow-up after each of the first two cycles with a consultation physical examination imaging studies and relevant laboratory tests to evaluate drug toxicity safety and tumor shrinkage rate
Adjustment and Transition to Surgery
Toxicity Management If intolerable drug toxicity or adverse reactions occur that cannot be managed by dose adjustment discontinue treatment immediately and switch to traditional surgical treatment
Post Two-Cycles Evaluation After the first two cycles if intolerable adverse reactions persist or the tumor continues to progress despite dose adjustments switch to traditional surgical treatment If the tumor does not progress continue long-term medication
Long-Term Treatment Follow-Up
Follow-Up Schedule Conduct follow-up evaluations every two cycles including consultations physical examinations imaging studies and relevant laboratory tests to evaluate drug toxicity safety and tumor shrinkage rate
Criteria for Surgery If tumor shrinkage reaches a plateau or the patient meets the criteria for mandibular preservation surgery and the surgical plan is confirmed independently by at least two chief physicians in the department record this in the case report form and discontinue the medication in preparation for scheduled surgery
Ⅰ To observe the proportion of patients with ameloblastoma requiring mandibular segmental resection at initial diagnosis who can convert to mandibular preservation surgery after preoperative induction therapy with dabrafenib and trametinib
ⅡTo observe the proportion of cases initially deemed non-radical resectable Surgery that become resectable
SECONDARY OBJECTIVES
Ⅰ Radiological response Ⅱ Pathological response Ⅲ Local recurrence-free survivalLRFS ⅣFeasibility and safety in this patient population
OUTLINE
Dabrafenib
Dosage 150 mg twice daily total daily dose of 300 mg Administration Must be taken in combination with trametinib until disease progression or intolerable toxicity occurs Administer at least 1 hour before or 2 hours after a meal with approximately 12 hours between doses Take at the same time each day If a dose is missed and less than 6 hours remain until the next dose the missed dose should not be taken When used in combination with trametinib take trametinib once daily at the same time as the morning or evening dose of dabrafenib Do not open crush or break the capsules
Trametinib
Dosage 2 mg once daily orally in combination with dabrafenib until disease progression or intolerable toxicity occurs
Administration Administer at least 1 hour before or 2 hours after a meal Take at the same time each day If a dose is missed it should be taken no later than 12 hours before the next scheduled dose If less than 12 hours remain until the next dose the missed dose should not be taken When used in combination with dabrafenib take trametinib once daily at the same time as the morning or evening dose of dabrafenib Do not chew or crush the tablets
Treatment Cycle
Cycle Length Each cycle lasts 30 days Initial Follow-Up Follow-up after each of the first two cycles with a consultation physical examination imaging studies and relevant laboratory tests to evaluate drug toxicity safety and tumor shrinkage rate
Adjustment and Transition to Surgery
Toxicity Management If intolerable drug toxicity or adverse reactions occur that cannot be managed by dose adjustment discontinue treatment immediately and switch to traditional surgical treatment
Post Two-Cycles Evaluation After the first two cycles if intolerable adverse reactions persist or the tumor continues to progress despite dose adjustments switch to traditional surgical treatment If the tumor does not progress continue long-term medication
Long-Term Treatment Follow-Up
Follow-Up Schedule Conduct follow-up evaluations every two cycles including consultations physical examinations imaging studies and relevant laboratory tests to evaluate drug toxicity safety and tumor shrinkage rate
Criteria for Surgery If tumor shrinkage reaches a plateau or the patient meets the criteria for mandibular preservation surgery and the surgical plan is confirmed independently by at least two chief physicians in the department record this in the case report form and discontinue the medication in preparation for scheduled surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None