A Phase IIB study of the tetramodal therapy of T2-T4 Nx M0 bladder cancerwith hyperthermia combined with chemoradiotherapy following TUR-BT

Kantonsspital Aarau AGZentrum für Radio-Onkologie KSA-KSB0 个研究点目标入组 40 人开始时间: 2014年7月9日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. urothelial (transitional cell) cancers of the bladder, T2 –T4, Nx, M0, except T2 R0 tumours, age at least 18 years, KPS at least 70 , medically inoperable patients, patients who decline radical cystectomy, fertile patients must use effective contraception during and for 12 months after study treatment, no pelvic radiotherapy during the last 12 months for non-malignant disease, any pelvic radiotherapy for malignant disease _ no active intractable or uncontrollable infection no prior or concurrent malignancy (less than 5 years prior to enrolment in study) except non-melanoma skin cancer, cervix carcinoma in situ, prostatic intraepithelial neoplasia), no contraindications to radiotherapy (for example connective tissue disorders such as scleroderma), no pre-existing uncontrolled cardiac disease, NYHA III-IV or persisting cardiac, arrhythmia under therapy, no myocardial infarction within the past 12 months, no cardiac pacemaker, no pelvic metal implants (with exception of non-clustered marker clips), absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

•pelvic radiotherapy during the last 12 months for non-malignant disease, any pelvic radiotherapy for malignant disease, active intractable or uncontrollable infection, prior or concurrent malignancy (less than 5 years prior to enrolment in study) except non-melanoma skin cancer, cervix carcinoma in situ, prostatic intraepithelial neoplasia), pre-existing uncontrolled cardiac disease, NYHA III-IV or persisting cardiac, arrhythmia under therapy, myocardial infarction within the past 12 months, cardiac pacemaker, pelvic metal implants (with exception of non-clustered marker clips), psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

发起方

Kantonsspital Aarau AGZentrum für Radio-Onkologie KSA-KSB