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临床试验/CTRI/2024/04/065583
CTRI/2024/04/065583尚未招募不适用

Super Selective Intra - Arterial Chemotherapy for Retinoblastoma - A Prospective Comparative Study

Dr Rajendra Prasad Centre for Ophthalmic Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Globe Salvage Rate

研究概览

简要总结

Retinoblastoma is the most common primary intraocular tumor with an incidence of 1: 16,000 to 18,000 live birth and represents 11% of cancers that develop in the first year of life. Retinoblastoma may be unilateral (60%) or bilateral (40%). Bilateral cases are heritable and median age of diagnosis is about 1 year. Unilateral cases are mostly non heritable but 15% can be heritable and median age of presentation is about 2 years.

Intra-arterial chemotherapy (IAC) is a relatively new technique for the management of advanced retinoblastoma.The Indications of IAC as Primary therapy/first-line management includes Unilateral retinoblastoma of groups B, C, and D and Bilateral retinoblastoma groups D and E. The Indications of IAC as Secondary therapy/second-line management include after prior treatment failure - Recurrent tumor, subretinal seeds or both - Persistent tumor, subretinal seeds or both.

This technique of intra-arterial chemotherapy (IAC) through ophthalmic artery has the advantage of higher concentration of chemotherapy drugs reaching the tumor, with negligible systemic side effects when compared with systemic intravenous.There are few systemic complications of IAC, including hematoma at groin entry site and transient pancytopenia from bone marrow suppression. Brain complications have been rarely encountered with carotid vascular spasm, stroke, and magnetic resonance imaging displaying focal perfusion defects. Local ocular toxicities of IAC relate mostly to vascular compromise of the ophthalmic artery, retinal artery, or choroidal vessels, cranial nerve palsy, orbit/eyelid oedema, retinal detachment, vitreous hemorrhage and retinal pigment epithelial changes. The retinal pigment epithelial changes could be related to previous retinal detachment or choroidal vascular compromise from chemotherapy toxicity.

Intra-arterial chemotherapy (IAC) for retinoblastoma involves the direct delivery of chemotherapeutic agents into the ophthalmic artery (OA). This approach is aimed at increasing drug delivery along with reduction of systemic side effects IAC has emerged as a promising option for globe salvage, particularly in advanced intraocular retinoblastoma This study will compare the outcomes of primary verses secondary Super Selective Intra-Arterial Chemotherapy in Retinoblastoma

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
0.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with Group B/ Group C / Group D Retinoblastoma (International Classification), Fit to undergo GA procedure, Informed Consent.

排除标准

  • Patients Diagnosed with Group A/ Group E Retinoblastoma (International Classification), Patients with Extraocular Spread / Systemic Metastasis, Patient/ LAR Not Willing for Treatment, Patient/ LAR Not Willing for Follow Up.

结局指标

主要结局

Globe Salvage Rate

时间窗: 4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS

次要结局

  • Procedure Success Rate(4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS)
  • Procedure Failure Rate(4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS)
  • Tumor Control Rate(4 WEEKS, 8 WEEKS, 12 WEEKS, 16 WEEKS, 20 WEEKS, 24 WEEKS)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR ANIKET LAXMIKANT RAMTEKE

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

研究点 (1)

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