Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 10
- 主要终点
- Event-free Survival
研究概览
简要总结
This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.
详细描述
PRIMARY OBJECTIVES:
I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy.
SECONDARY OBJECTIVES:
I. Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients.
II. Correlate response rate with event-free survival in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Group B intraocular retinoblastoma meeting 1 of the following criteria:
- •Group B tumor(s) in 1 eye
- •Group B tumor(s) in both eyes
- •Group A tumor in 1 eye and Group B tumor(s) in the other eye
- •Group E tumor in 1 eye that has been enucleated and Group B tumor(s) in the remaining eye at the time of enucleation of the Group E tumor
- •Defined by the International Classification System for Intraocular Retinoblastoma as follows:
- •Group A: Small tumors (≤ 3 mm in greatest dimension) confined to the retina, away from foveola and disc meeting the following criteria:
- •More than 3 mm from fovea
- •More than 1.5 mm from optic disk
- •Group B: Tumors more than 3 mm meeting the following criteria:
- •Confined to the retina in any location not in Group A
- •Tumor associated subretinal fluid < 3 mm from the tumor margin with no subretinal seeding
- •Group E: Must have ≥ 1 of the following present:
- •Tumor touching the lens
- •Tumor anterior to anterior vitreous face involving ciliary body or anterior segment
- •Diffuse infiltrating retinoblastoma
- •Neovascular glaucoma
- •Opaque media from hemorrhage
- •Tumor necrosis with aseptic orbital cellulites
- •Phthisis bulbi
- •Confirmation of diagnosis by CT scan or MRI of the brain and orbits AND an ophthalmologic evaluation under anesthesia within the past 3 weeks
- •No choroidal and/or optic nerve invasion past the lamina cribosa
- •No evidence of extraocular retinoblastoma clinically or by head and orbital MRI and/or CT scan
- •No tumor present on histological exam at the cut end of the optic nerve for any Group E eye enucleated before study entry
- •Performance status - ECOG 0-2
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- •AST or ALT < 2.5 times ULN for age
- •Creatinine clearance (based on Schwartz formula) or radioisotope glomerular filtration rate ≥ 70mL/min/1.73 m^2
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •No prior radiotherapy
- •No other concurrent radiotherapy, including intensity-modulated stereotactic, or proton beam radiotherapy
- •Prior enucleation of one eye allowed provided the remaining eye is Group B
- •No concurrent enucleation
- •No prior local ophthalmic therapy for retinoblastoma
- •No other prior therapy for retinoblastoma
- •No local therapy during chemotherapy course 1
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
干预措施: Carboplatin (Drug)
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
干预措施: Cryosurgery (Procedure)
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
干预措施: Infrared Laser Therapy (Procedure)
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
干预措施: Iodine I-125 (Radiation)
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
干预措施: Radiation Therapy (Radiation)
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
干预措施: Ruthenium Ru-106 (Radiation)
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
干预措施: Vincristine Sulfate (Drug)
结局指标
主要结局
Event-free Survival
时间窗: At 2 years
Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.
次要结局
- Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0(6 months after enrollment)
- Response Rate (RR) at Patient Level After the First Course of Therapy(1 month after enrollment)
- Response Rate (RR) at Eye Levels After the First Course of Therapy(1 month after enrollment)
- Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level(2 years after enrollment)