Oral Chlorophyllin for the Prevention of Toxicity in Radiotherapy for Bladder Cancer: A Phase II trial - NIl

Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

研究概览

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•1.Patients should have histologically proven Urothelial carcinoma or Urothelial Carcinoma with squamous and Adeno. Differentiation and should be eligible for bladder preservation using radiotherapy/chemoradiotherapy.
•2.Patients should have clinical stage T1-T4 cancer.
•3.Patients nodal stage should be N0-N1.
•4.Patients must be treated with conventional or moderately hypofractionated radiotherapy.
•5.Patient should not have any history of pelvic radiation.
•6.Adequate Renal Function S.Creatinine <=1.5x upper limit of normal(1.3 mg/dl in men;1.1 mg/dl in female)
•7.Adequate Hepatic Function: Total billirubin <=1.5 x institutional upper limit of normal (1.2 mg/dl)
•8.Patients must be able to understand and willingness to sign the written informed consent.

•1.Patients with known hypersensitivity or contraindications to chlorophyllin
•2.Patients with distant metastasisÂ¬Â¬Â¬Â¬
•3.Patients treated with palliative intent or partial bladder RT
•4.Chronic active infections such as HIV, Hepatitis B, Hepatitis C
•5.Women who are pregnant or breast-feeding
•6.Uncontrolled Diabetes Mellitus (RBS:>=180 mg/dl), Hypertension(>=140/90 mm hg) on regular medication

发起方

Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre