2023-504699-73-00已完成2 期
The evaluation of the effectiveness, safety and tolerability of treatment, using a specialized prostate-specific membrane antigen (PSMA) labeled with Lutetium177, in patients with recurrent and/or metastatic adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年9月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)
研究概览
简要总结
Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Giving written informed consent to participate in the study.
- •Patients with unresectable, locoregionally advanced or metastatic, histopathologically proven Adenoid Cystic Carcinoma of salivary glands.
- •Age over 18 years.
- •WHO Performance Status 0 to
- •68Ga-PSMA PET/CT proven expression of PSMA; a positive result is considered as a qualitative assessment equal or greater than accumulation in functional liver.
- •Progression of disease confirmed by imaging scans according to RECIST 1.1 criteria.
- •Adequate function of: Bone marrow - neutrophils >1500x109/L; thrombocytes >150 000x109/L, hemoglobin >9 g/dl; Liver - bilirubin <2xULN (upper limit of normal range); aminotransferase <3xULN (patients with liver metastases <5xULN); Kidneys - eGFR >50 ml/min; Albumins >2,5 mg/ml
- •In women with procreative ability: confirmed negative pregnancy test result and consent to the implementation of double barrier contraception method.
- •In men with procreative ability: consent to the implementation of double barrier contraception method.
排除标准
- •Pregnancy or breastfeeding.
- •Lack of effective contraception in childbearing age.
- •Patients with brain, cerebral meninges or heart metastases.
- •Severe or significant concomitant disease in the investigator's assessment.
- •Urinary tract obstruction or/and hydronephrosis.
- •Concurrent anticancer treatment.
- •Myelosuppressive or nuclear treatment within 4 weeks before enrollment to the study.
结局指标
主要结局
Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)
Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)
次要结局
- Objective response rate (ORR) – assessment in CT scan according to RECIST 1.1 score – 2 years after completion of the treatment
- Progression free survival (PFS) - assessed from the start of treatment to the time of disease progression or death
- Overall survival (OS) – assessed from the start of treatment to the time of death
- Duration of response (DoR) – assessed from inclusion in the study to the time of progression or death in patients who achieved a complete or partial response - only patients in remission will have this parameter assessed
- Quality of life assessment (according to EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaires) – assessed from enrollment in the study to 2 years after completion of the treatment
研究者
Centrum Wsparcia Badań Klinicznych
Scientific
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
研究点 (1)
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