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JOURNAL ONKOLOGIE – STUDIE
HyBla_RCT

Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia

Rekrutierend

NCT-Nummer:
NCT05397262

Studienbeginn:
März 2017

Letztes Update:
31.05.2022

Wirkstoff:
Chemotherapy 5-Fluorouracil, Chemotherapy Cisplatin

Indikation (Clinical Trials):
Urinary Bladder Neoplasms, Hyperthermia, Fever

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

Oliver Ott, MD
Principal Investigator
Dept. of Radiation Therapy, University Hospital Erlangen

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

Brief Summary:

Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination

with radiotherapy and chemoradiotherapy in bladder cancer

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥ 18 years

- Histologically confirmed bladder cancer

- M0

- ECOG-performance status ≤ 2

- Informed consent

Exclusion Criteria:

- Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm

disturbances requiring therapy

- Cardiac Pacemaker

- Myocardial infarction within the past 12 months

- Congestive heart failure

- Complete bundle branch block

- New York Heart Association (NYHA) class III or IV heart disease

- Disease that would preclude TUR, chemoradiation or deep regional hyperthermia

- Metal implants (lenght > 2cm or dense clusters of marker clips in the pelvis)

- Active or therapy-resistent bladder infections

- Pre-existing or concommitant immunodeficiency Syndrom

- Pregnant or lactating women

- Patients not willing to use effective contraception during and up to 6 months after

therapy

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - Participants will be followed for up to 5 years after the end of therapy):
Overall survival



Secondary outcome:

1. Bladder preservation rate (Time Frame - Participants will be followed for up to 5 years after the end of therapy):
Rate of patients where bladder can be preserved

2. Disease free survival (Time Frame - Participants will be followed for up to 5 years after the end of therapy):
Length of survival without disease recurrence

Geprüfte Regime

  • Hyperthermia (Thermal therapy or thermotherapy):
    Deep Regional Hyperthermia (RHT) 1-2/week up to 10 sessions a type of cancer treatment in which body tissue is exposed to high temperatures (up to 113°F).
  • Radiotherapy:
    50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
  • Chemotherapy 5-Fluorouracil:
    600 mg/m^2 civ 120h; d 1-5, 29-33
  • Chemotherapy Cisplatin:
    20 mg/m^2; d1-5, 29-33

Quelle: ClinicalTrials.gov


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