NCT03514888已完成不适用
A Pilot Study for Hyperthermic Intraperitoneal Chemotherapy After Radical Cystectomy With Pelvic Lymph Node Dissection for High Risk Invasive Bladder Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Treatment toxicity
研究概览
简要总结
This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk factors for tumor recurrence.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary urothelial cell carcinoma of the bladder
- •Patient's aged 45-85, both genders.
- •ECOG performance status < 1
- •Hematology: ANC > 1.5x109/L; Platelets > 100x109/L
- •Women with child bearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- •Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
- •Either any of the following preoperative factors for increased risk of recurrence:
- •Lymphovascular invasion
- •Variant histology in the background of primary urothelial (notably plasmacytoid)
- •Clinical T3 or greater
- •Clinical N+
- •No prior neoadjuvant chemotherapy (NAC) or lack of response to NAC
- •Or any of the following perioperative factors for increased risk of recurrence:
- •Palpable concern for extravesical disease
- •Tumor spillage/bladder entry
- •Suspicious nodes or positive intraoperative frozen sections
排除标准
- •Subjects who have previously undergone intraperitoneal chemotherapy.
- •Subjects with tumor histology other than urothelial cell carcinoma.
- •Patients on concurrent anti-cancer therapy other than that allowed in the study.
- •Other prior malignancies, except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix or adequately treated malignancies for which there has been no evidence of activity for more than 3 years.
- •Subjects with renal insufficiency defined as creatinine > 1.5x the upper limit of normal or a calculated creatinine clearance of < 50 cc/min.
- •Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
- •Known HIV, Hepatitis B or Hepatitis C positive.
- •Subjects with uncontrolled concurrent illness including, but not limited to, ongoing or severe infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, acute gastrointestinal bleeding, psychiatric illness or other condition which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study.
- •Any condition that would preclude the ability to deliver appropriate IP therapy.
结局指标
主要结局
Treatment toxicity
时间窗: 90 days
Treatment toxicity will be analyzed using NCI Common Terminology Criteria for Adverse Events-Version 4.0. Descriptive statistics will be used to determine proportion of grade III/V treatment toxicity. Expected grade III/V toxicity in surgical patients without HIPEC would be 3 out of 10 patients. With the addition of HIPEC, there would be a significant difference (p=0.05) if 6 out of 10 patients experienced a grade III/V toxicity. Therefore, if less than 6 patients experience a grade III/V we would consider this a "negative" finding.
次要结局
未报告次要终点
研究者
研究点 (1)
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