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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006287

Enrollment

Registered

2014-07-09

Start date

2013-04-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C67

Interventions

Group 1: Hyperthermia combined with chemoradiotherapy following TUR-BT. Pelvic irradiation (Monday-Friday) starts 4-6 weeks after transurethral tumor resection of the bladder tumour. The hyperthermia

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Complete response 6 weeks after treatment	—

Secondary

Measure	Time frame
sustained CR 6 months after completion of therapy, functional bladder preservation at 1 and 2 years, grade III-IV acute/late toxicities according to CTCAE, Quality of Life according to EORTC QLQ – C30 and QLQ – BLM 30, progression free survival at 2 years after registration, overall survival at 2 years after registration,	—

Countries

Switzerland

Contacts

Public ContactTherese Gurtner

Kantonsspital Aarau AG

-+41628386058

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026