NCT05395962招募中2 期
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
适应症
干预措施
相关药物
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
- Compare Local progression-free survival
研究概览
简要总结
Patients with vulvar cancer who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), or patients not eligible for standard therapies.
The study aims to:
- Evaluate the oncology response to electroporation after administration of Bleomycin (BLM) + carboplatinum (CBP )to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.
- Compare quality of life (HR-QoL) in the two groups of patients with questionnaires (FACT-V, FACT-PAL, E5-5L-D5).
- To compare Overall Survival in the two study arms.
- To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms.
- To compare costs and cost-effectiveness between the two study arms.
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
- 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:
- •Bone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 109/L?) o INR >1.5;
- •Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 × upper limit of normal (ULN)
- •Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert's syndrome
- •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.
研究组 & 干预措施
BLM
Active Comparator
干预措施: Bleomycin (Drug)
BLM+CBP
Experimental
干预措施: Carboplatin (Drug)
BLM+CBP
Experimental
干预措施: Bleomycin (Drug)
结局指标
主要结局
Compare Local progression-free survival
时间窗: 5 years
Evaluate the oncology response to electroporation after administration of BLM + CBP to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.
次要结局
- Compare Overall Survival(5 years)
- Reporting of Adverse Events and Serious Adverse Events(5 years)
- Compare Health-Related Quality of life (HR-QoL) in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone assessed with questionnaires in patients undergoing BLM + CBP vs BLM alone assessed with questionnaires.(5 years)
- Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the EQ-5D-5L (5-level EQ-5D version) questionnaire.(5 years)
- Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACT-V (Functional Assessment of Cancer Therapy-Vulva) questionnaire.(5 years)
- Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACIT-PAL ( Functional Assessment of Chronic Illness Therapy - Palliative Care) questionnaire.(5 years)
研究者
Anna Myriam Perrone
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究点 (1)
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