NCT02843386已完成3 期
Randomized Phase III Study Comparing an Adjuvant Chemotherapy With Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 6
- 主要终点
- Metastasis-Free survival
研究概览
简要总结
After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external radiotherapy) patients with high risk of metastasis are randomized between:
- Adjuvant chemotherapy with Fotemustin.
- Observation
Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.
详细描述
High risk uveal melanoma is defined by :
- Clinical criteria: Largest Tumor Diameter ≥ 15 mm with extra scleral extension and/or retinal detachment or Largest Tumor Diameter ≥ 18 mm AND/ OR
- Genomic high risk signature (aCGH +/-LOH): Monosomy 3 or partial deletion of 3p associated with any 8 gain.
Treatment schedule :
- Induction: Fotemustin 100 mg/m², D1-D8-D15, 1 hour IV infusion, 1 cycle
- Maintenance : restart on D50, Fotemustine : 100 mg/m², 1 hour IV infusion, D1 D21, 5 cycles.
Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk uveal melanoma, defined by :
- •Clinical criteria: Largest Tumor Diameter ≥ 15 mm with extrascleral extension and/or retinal detachment or Largest Tumor Diameter ≥ 18 mm AND/OR
- •Genomic high risk signature (cCGH +/- LOH) : Monosomy 3 or partial deletion of 3p and any 8 gain, from enucleation, transscleral or transvitreal samples
- •Age ≥ 18 years and ECOG Performance Status ≤ 2
- •No prior chemotherapy or history of invasive cancer < 5years
- •No metastases
- •Local treatment for the primary tumour (surgery and/or radiotherapy) achieved ≤ 30 days from randomization, chemotherapy to begin within 15 days.
- •6 - Contraception in women of child-bearing potential
- •7- Written informed consent
- •8- Patients with French Social Security in compliance with the French law relating to biomedical research.
- •Non-Inclusion Criteria:
- •Largest Tumor Diameter < 15 mm or Largest Tumor Diameter 15-18 mm without extrascleral extension and/or retinal detachment, in the absence of genomic alteration as defined per protocol or in the absence of Fine Needle Aspiration biopsy for genomic risk assessment.
- •Contraindication to Fotemustine administration
- •Hematological function : Hb < 10g/dL, absolute neutrophil count < 2,000/mm3, and platelets < 100,000/mm3
- •Biochemistry results :Total bilirubin and AST/ALT > 1,5 UNL (Upper Normal Limit)
- •Creatinine > 1,5 UNL (Upper Normal Limit)
- •Pregnant and/or breastfeeding women.
- •8 - Previous history of cancer excepting in situ cervical carcinoma or cutaneous basal carcinoma.
- •7- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, viral or other hepatitis or cirrhosis, or psychiatric illness/social situation that would interfere with the protocol or limit compliance with study requirements.
排除标准
- 未提供
研究组 & 干预措施
A : Chemotherapy
Experimental
Adjuvant chemotherapy by Fotemustin 100mg/m²
干预措施: Adjuvant chemotherapy by Fotemustin (Drug)
B : Surveillance
Other
Intensive surveillance
干预措施: Intensive surveillance (Other)
结局指标
主要结局
Metastasis-Free survival
时间窗: 3 years
Time between patient randomization and metastases occurrence or death
次要结局
- Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities(3 years)
- Overall Survival(3 years)
- Quality of life assessment(Baseline, 6 months and 3 years)
研究者
研究点 (6)
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