A PHASE 2, SINGLE CENTRE, SINGLE ARM STUDY TO DETERMINE THE EFFICACY AND SAFETY OF 5- ALA POHOTODYNAMIC THERAPY AS ADJUVANT THERAPY AFTER SURGICAL DISSECTION IN PATIENTS WITH DESMOID TUMORS.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- The primary endpoint is a binary variable where each patient is classified as a recurrence or a not recurrence case and will be determined by calculating the proportion of recurrence versus non recurrence rates
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral administration and subsequently intraoperative tumor bed phototherapy with red light laser, as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid tumors. To evaluate the Safety of 5-ALA administration. 5 years local recurrence rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient has a resectable histologically confirmed desmoid tumor.
- •Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
- •Age > 18 years
- •Signed informed consent prior to patient recruitment. -
排除标准
- •Hepatic enzymes or bilirubin > 2X upper limit of normal.
- •Serum creatinine > 2.5 x upper limit of normal.
- •Suspected /documented metastatic disease.
- •Active or uncontrolled infections.
- •Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) < 2 years prior to the study.
- •Use of other investigational agents < 30 days prior to the study.
- •Patients who are mentally or physically unable to comply with all aspects of the study.
- •Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- •Pregnant or lactating females.
- •Known intolerance or allergy to 5-ALA
- •Suspicious or documented acute or chronic porphyria
研究组 & 干预措施
5-AminoLevulinicc Acid
consists of 60mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia and surgical tumor resection. Red light laser given by a Dye laser system, wave length of 635nm, in s dose of 150J/cm for 2000 seconds (33 minutes) will be given to tumor bed. In the case of positive margins (for tumor presence), a second surgical intervention followed by second 60mg/kg 5-ALA administration will be performed.
干预措施: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. (Drug)
结局指标
主要结局
The primary endpoint is a binary variable where each patient is classified as a recurrence or a not recurrence case and will be determined by calculating the proportion of recurrence versus non recurrence rates
时间窗: three years
次要结局
- To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.(five years)
研究者
michal roll
Director research and development department
Tel-Aviv Sourasky Medical Center