EUCTR2013-002628-18-ES进行中（未招募）不适用
HIVEC (Hyperthermic IntraVEsical Chemotherapy) FOR PATIENTS WITH INTERMEDIATE RISK NMIBC COMPARED WITH STANDARD INTRAVESICAL INSTILLATION OF CHEMOTHERAPY AS ADYUVANT TREATMENT. A COMPARATIVE, PROSPECTIVE, RANDOMIZED STUDY. - HIVEC I
COMBAT MEDICAL LTD0 个研究点开始时间: 2013年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. New or Recurrence of intermediate risk NMIBC following TURBT defined as;
- •? Grade 2 or grade 1 stage T1 disease
- •? Any grade G2 or G1 other than Low risk
- •2. Age ? 18 yrs
- •3. WHO performance status 0, 1, 2, 3
- •4. Normal kidneys and ureters on imaging study within the past 12 months**
- •5. Pre-treatment haematology and biochemistry values within acceptable limits:
- •- haemoglobin ? 10 g/dl
- •- neutrophil count ? 1.5 x 109/l
- •- platelets ? 100 x 109/l
- •- WBC ? 3.0 x 109/l or ANC ? 1.5 x 109/l
- •- Serum creatinine < 1.5 x UNL
- •6. Negative pregnancy test for women of child-bearing potential.
- •7. Available for long-term follow-up.
- •8. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patients with any of the following conditions:
- •- Grade 3 UCC.
- •- Primary Solitary Ta G1<3cm
- •- Primary Solitary Ta G2 <3cm
- •2. ?T2 UCC
- •3. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
- •4. History of limited vesical capacity (<200cc)
- •5. UCC involving the prostatic urethra or upper urinary tract.
- •6. Known allergy to MMC
- •7. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
- •8. Other malignancy within the past five years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer with less than 5yrs life expectancy.
- •9. Patients with tumours histologically different tan transitional cell carcinoma
- •10. Concurrent chemotherapy.
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