NL-OMON38450撤回2 期
Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) - Pre-TURBT TheraCoat bladder instillation
Sintesi Research0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria
- •1. Patient is 21 years of age or older
- •2. Patient has signed Informed Consent Form and is willing and able to abide by the protocol
- •3. Single or multiple tumors (n<=7)
- •4. Recurrent tumor
- •5. No prior history of HG and/or T1 and/or Tis
- •6. At least one Tumor >= 1mm as evaluated visually by the investigator
- •7. Largest tumor diameter <= 30mm as evaluated visually by the investigator
- •8. Cystoscopic appearance of papillary Low grade tumor
- •9. The patient had upper urinary tract evaluation in the previous year excluding urothelial carcinoma, hydronephrosis or Renal Cell Carcinoma or other renal cancers
- •10. Good performance status (Karnofsky performance status 70% or greater)
- •11. No active urinary tract infection as confirmed by urine culture
- •12. If the patient is a female of childbearing potential she is using an acceptable/effective method of contraception
- •13. If the patient is a female of childbearing potential she has a negative pregnancy test at screening
排除标准
- •Exclusion criteria
- •1. Carcinoma In Situ (CIS)
- •2. Over 7 lesions
- •3. Lesion is larger than 30mm in diameter
- •4. First presentation of bladder tumor
- •5. High Grade urine cytology
- •6. Tumor located in prostatic urethra
- •7. Previous systemic chemotherapy or pelvic radiotherapy
- •8. Pregnant or breastfeeding patient
- •9. Previous treatment with BCG within the last 24 months
- •10. The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening
- •11. Treatment with intravesical chemotherapy within the 3 last months
- •12. The patient has/had any bladder tumor with histology other than TCC
- •13. Contraindication to MMC
- •14. The patient has a history of urinary retention or a PVR>=250cc by bladder scan or ultrasound (PVR test may be repeated up to 3 times)
- •15. The patient has a bleeding disorder or a screening platelet count <50X109/L
- •16. The patient has screening hemoglobin <10mg/dL
- •17. The patient has a history of Acquired Immunodeficiency Syndrome or HIV positive
- •18. The patient has a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g. uncontrolled diabetes, compensated congestive heart failure (NYHA III and over), myocardial infarction within 6 months of study, unstable or uncontrolled hypertension or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion
- •19. The patient participated in an investigational protocol within the past 90 days
- •20. The patient has life expectancy of <3 years
- •21. The patient had another malignancy or received therapy for any malignancy in the last five years except for:
- •Non-melanoma skin tumors
- •stage 0 (in situ) cervical carcinoma
- •22. The patient has documented vesico-ureteral reflux or an indwelling ureteral stent
- •23. The patient has the tumor in the bladder diverticulum
研究者
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