CLINICAL OUTCOMES OF GAMMA KNIFE AND RUTHENIUM PLAQUE BRACHYTHERAPY IN THE TREATMENT OF UVEAL MELANOMA
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
- 2. Local tumor control-
研究概览
简要总结
Uveal Melanoma is the most common primary malignant intraocular tumor in adults with 80% of them originating in choroid.This study aims at evaluating the clinical outcomes of two globe salvage therapies that is Stereotactic Radiosurgery using Gamma Knife and Ruthenium Plaque Brachytherapy in the treatment of Uveal Melanoma.The study design is a prospective interventional study with 20 patients - with 10 of them being subjected to Gamma Knife and 10 of them being subjected to Ruthenium Plaque Brachytherapy. The patients shall be subjected to one of the two treatment modalities and followed up for a minimum period of 6 months. At each visit, patients will be assessed for all clinical parameters,and investigated through OCT and USG. MRI Orbit will be done at 6 months. Globe Salvage Rate, local tumor control, vision salvage rate , development of local complications, local recurrence of tumor and need for enucleation shall be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •A) CHOROIDAL MELANOMA
- •GAMMA KNIFE
- •Small,medium and large choroidal melanoma according to COMS Classification.
- •Patients giving consent for the study
- •RUTHENIUM PLAQUE BRACHYTHERAPY
- •Small to medium(thickness <7mm ) choroidal melanoma according to COMS Classification.
- •Patients giving consent for the study B) IRIS/CILIARY MELANOMA
- •Patients giving consent for the study 2) RUTHENIUM PLAQUE BRACHYTHERAPY 1.
排除标准
- •A) CHOROIDAL MELANOMA
- •GAMMA KNIFE
- •Tumors with gross extraocular extension
- •Patients with painful blind eye
- •Presenting with metastatic choroidal melanoma
- •RUTHENIUM PLAQUE BRACHYTHERAPY
- •Presenting with metastatic choroidal melanoma B) IRIS/ CILIARY BODY MELANOMA
- •Seeding in anterior chamber
- •Melanomas with secondary glaucoma
- •Scleral/extraocular extension
- •Tapioca/ Ring Melanoma
- •Tapioca/ Ring Melanoma.
结局指标
主要结局
2. Local tumor control-
时间窗: 6 months
%decrease in tumor diameter
时间窗: 6 months
3. Vision salvage rate-assessing post procedure visual outcomes
时间窗: 6 months
5. Need for enucleation
时间窗: 6 months
extension
时间窗: 6 months
1. Globe salvage rate-percentage of cases where enucleation was not required
时间窗: 6 months
and height on USG.
时间窗: 6 months
7. Occurence of Distant
时间窗: 6 months
4. Local recurrence of tumor
时间窗: 6 months
6. Occurence of Extraocular
时间窗: 6 months
metastasis
时间窗: 6 months
次要结局
- Development of local complications subsequent to therapy:(1. Radiation Retinopathy)