A Phase II study to evaluate oral chlorophyllin in hemorrhagic cystitis secondary to radiation therapy for pelvic malignancies - CLARITY Trial

Bhabha Atomic Research Center BARC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

暂无简介。

•1.Patients >= 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back
•2.Any grade of radiation induced cystitis as per RTOG criteria (RTOG Grade 1-4 equivalent to CTCAE Grade 1-3)
•3.Adequate liver function defined as ALT/ALT <= 3 times ULN and total bilirubin <= 2 times ULN. Elevated transaminases up to 5 times ULN is allowed in patient with liver metastasis.
•4.Adequate renal function defined as creatine clearance >= 30 mL/min (By Cockcroft-Gault formula)
•Further evaluation of severity of hemorrhagic cystitis and response assessment during the study will be done using CTCAE criteria

•1.Known hypersensitivity or contraindications against sodium chlorophyllin
•2.Hemodynamically unstable patients not responding to initial resuscitation
•3.Patients with life threatening hemorrhagic cystitis requiring urgent invasive intervention (CTCAE grade 4)

发起方

Bhabha Atomic Research Center BARC