A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Lower urinary tract symptoms
研究概览
简要总结
Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria.
Prior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study.
The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS.
BCG or MMC will be started within 1-2 weeks from randomization (within 12-14 weeks after TURB).
BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment.
48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation.
BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation.
After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed.
After 6 and 18 weeks from instillation therapy end, a control visit will be made.
A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.
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
- •Male or female ≥ 18 years of age
- •ECOG PS 0-2
- •Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve and recurrent.
- •Patients candidate to BCG or MMC intravesical induction therapy.
- •Transurethral resection (TURB/re-TURB when indicated) performed in the last 12 weeks.
- •IPSS score ≤19
- •Negative urine culture within 2 weeks before T0
- •For women who are not postmenopausal (i.e., < 1 year after last menstruation) or surgical-ly sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive de-vice, or barrier method of contraception in conjunction with spermicidal jelly) during the study period
- •Signed the study informed consent prior to any study specific procedures.
- •Will and ability to comply with the protocol
排除标准
- •Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral stenosis; difficult catheterization; reduced bladder compliance; increased bladder compliance; post-voiding residue > 150 ml;
- •Surgery or invasive procedures planned during the study and interfering with evaluation about efficacy and safety of it.
- •Female patients with child-bearing potential must not be pregnant or lactating, or not willing to use adequate contraception for the duration of study
- •Pelvic radiotherapy within 24 weeks prior to the beginning of the study treatment.
- •Urinary tract infection requiring antibiotics
- •Have a known hypersensitivity to any substance present in the investigational device.
- •Neurogenic bladder
- •Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the subject.
研究组 & 干预措施
Arm A (interventional arm)
patients receive Hydeal Cyst intravesical instillations during the BCG or MMC therapy period.
干预措施: Hydeal Cyst® (Device)
Arm B (control arm)
patients receive only standard therapy (BCG or MMC).
结局指标
主要结局
Lower urinary tract symptoms
时间窗: From the date of randomization up to 22 weeks
Lower urinary tract symptoms will be evaluated by the IPSS questionnaire (score 0-35) at baseline and follow-up visits. Difference from baseline will be calculated at two weeks after the end of induction cycle of intravesical instillation.
次要结局
- Recurrence free survival (RFS)(From the date of randomization up to 22 weeks)
- Progression free survival (PFS)(From the date of randomization up to 22 weeks)
- Quality of Life assessment(From the date of randomization up to 22 weeks)
- Toxicity during the treatment(From the date of randomization up to 22 weeks)