2024-518370-14-00招募中2 期
Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年11月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- local progression free survival
研究概览
简要总结
The primary objective of this study is to evaluate whether BLM + AUC2-CARBOPLATIN is superior to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed VC after multimodal treatments (surgery and radiotherapy/chemoradiation)
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old - Recurrent VC confirmed by histological examination - Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy). - Patient not eligible for standard therapies (surgery, radiation therapy and systemic chemotherapy in case of metastatic disease) due to the performance status (ECOG Performance Status ≥ 3 ) - Life expectancy more than three months - Measurable disease according to RECIST 1.1 - Adequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), and coagulation parameters as follows: o Bone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 109/L?) o INR >1.5; o Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 × upper limit of normal (ULN) o Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert’s syndrome o Serum creatinine <1.5 mg/dl and creatinine clearance > 30 ml/min All blood assessments must be performed within 15 days from ECT treatment. - For females of childbearing potential, a negative serum pregnancy human chorionic gonadotropin (hCG) pregnancy test within 72 hours of study Day
- •Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply the study requirements.
排除标准
- •History of other malignancies in the previous five years, except basal cell carcinoma of the skin. - History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule. - Allergic reactions to the two chemotherapy drugs (BLM and AUC2-CARBOPLATIN) and/or their excipients. - Evidence of pulmonary fibrosis. - History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification ≥ II [NYHA 1994]), myocardial infarction within 6 months of study entry. - Patients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded). - Pregnant or breastfeeding. - Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study
结局指标
主要结局
local progression free survival
local progression free survival
次要结局
未报告次要终点
研究者
Anna Myriam Perrone
Scientific
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
研究点 (1)
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