2024-514025-30-00招募中2 期
RETINO 2018: conservative treatment for retinoblastoma: efficacy of the new management strategies and visual outcome
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 28
- 主要终点
- Study 1: Rate of eye preservation in the investigational arm (Topotecan + Melphalan) and in the reference arm (Melphalan) 24 months after the date of randomization.
研究概览
简要总结
- Study 1: To evaluate the efficacy of IAC in term of local control of the disease in patients eligible for IAC (randomized phase II study);
- Study 2: To assess the visual function, based on World Health Organization (WHO) criteria, in patients eligible for other conservative treatments (IV chemotherapy in association with local ophthalmologic treatments or local ophthalmological treatment without IV chemotherapy; this is a minimally invasive interventional study).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Overall study inclusion criteria: Newly diagnosed RB.
- •Study 2 inclusion criteria: RB eligible for conservative management although not manageable with IAC: a. Unilateral RB in children below 6 months of age, classified as Group A, B, C or D, with or without vitreous seeding, compatible with conservative management, or b. Bilateral RB classified as group A, B, C D, or E without invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye and eligible for conservative management.
- •Overall study inclusion criteria: RB with at least one eye eligible for conservative management
- •Overall study inclusion criteria: Patients likely to be compliant with the study requirements and visits, including late follow-up.
- •Overall study inclusion criteria: Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.
- •Overall study inclusion criteria: Patients with no contraindication to the proposed treatments.
- •Overall study inclusion criteria: Informed consent signed by parents or legal representative
- •Overall study inclusion criteria: French Social Security System coverage.
- •Study 1 inclusion criteria:Children aged from 6 months to 6 years.
- •Study 1 inclusion criteria: RB in at least one eye, deemed manageable with IAC in one side and without IV chemotherapy: a. Unilateral RB classified as group B, C (if vitreous seeds < 3 mm), D or E with no invasion of the anterior segment, and without massive tumor of more than 2/3 of the eye, eligible for conservative management, or b. Bilateral RB but with very unbalanced lesions between the two eyes: one eye group D or E without invasion of the anterior segment or massive tumor of more than 2/3 of the eye, eligible for IAC, and the other eye eligible for local treatment only (without IAC).
排除标准
- •Overall study non-inclusion criteria: RB not eligible for conservative management : a. Extra-ocular extension of the disease, or b. Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye.
- •Study 1 non-inclusion criteria: Any contraindication or concomitant disease that would preclude the Study 1 treatment procedure and could delay treatment.
- •Overall study non-inclusion criteria: Patient older than 6 years of age.
- •Overall study non-inclusion criteria:Patients with another associated disease contra indicating systemic chemotherapy.
- •Overall study non-inclusion criteria: Previously treated retinoblastoma by chemotherapy
- •Overall study non-inclusion criteria: Patients already treated for another malignant disease
- •Overall study non-inclusion criteria: Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Overall study non-inclusion criteria: Patients whose parents have not accepted the treatment regimen after explanation of it.
- •Overall study non-inclusion criteria: Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs
- •Overall study non-inclusion criteria: Inclusion in another experimental anti-cancer drug therapy
结局指标
主要结局
Study 1: Rate of eye preservation in the investigational arm (Topotecan + Melphalan) and in the reference arm (Melphalan) 24 months after the date of randomization.
Study 1: Rate of eye preservation in the investigational arm (Topotecan + Melphalan) and in the reference arm (Melphalan) 24 months after the date of randomization.
Study 2: Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension, when the patient will have 6 years of age and at least 24 months of follow-up after study inclusion.
Study 2: Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension, when the patient will have 6 years of age and at least 24 months of follow-up after study inclusion.
次要结局
未报告次要终点
研究者
Livia LUMBROSO - LE ROUIC
Scientific
Institut Curie
研究点 (28)
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