Trial document





This trial has been registered retrospectively.
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  DRKS00003397

Trial Description

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Title

Prospectively randomized, double-blind, multicenter phase II trial comparing the efficacy of chemotherapy with gemcitabine plus cisplatin and sorafenib versus gemcitabine plus cisplatin and placebo in the treatment of advanced or metastatic urothelial carcinoma SUSE - AB 31/05

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Trial Acronym

SUSE - AB 31/05

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URL of the Trial

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Brief Summary in Lay Language

Trial comparing the efficacy of chemotherapy with gemcitabine plus cisplatin and sorafenib versus gemcitabine plus cisplatin and placebo in the treatment of advanced or metastatic urothelial carcinoma.
This study is based on the hypothesis that sorafenib can improve the efficacy of combination chemotherapy in patients with advanced urothelial cancer.
The main target is the 5 year survival free of recurrent disease.
Potential study participants are patients with advanced bladder cancer.

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Brief Summary in Scientific Language

Trial comparing the efficacy of chemotherapy with gemcitabine plus cisplatin and sorafenib versus gemcitabine plus cisplatin and placebo in the treatment of advanced or metastatic urothelial carcinoma.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003397
  •   2012/01/13
  •   2010/10/01
  •   yes
  •   Approved
  •   06-2998, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   2005-006098-29 
  •   NCT01215266  (clinical-trials.gov)
  •   4031573 
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Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
  •   bladder cancer
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Interventions/Observational Groups

  •   - Gemcitabin 1250 mg/m2, day 1 + 8, intravenous
    - Cisplatin 70 mg/m2, day 2, intravenous
    - Sorafenib 2 x 400 mg, day 3 - 21, orally
  •   - Gemcitabin 1250 mg/m2, day 1 + 8, intravenous
    - Cisplatin 70 mg/m2, day 2, intravenous
    - Placebo 2 x 2 tablets, day 3 - 21, orally
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

Progression free survival [ Time Frame: 5 years ]

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Secondary Outcome

- Response rates, time of response [ Time Frame: 5 years ]
- Time to progression [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Evaluation and comparison in both treatment arms [ Time Frame: 5 years ]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2006/10/09
  •   132
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

- Condition ECOG(Eastern Cooperative Oncology Group) 0-1
- Life expectancy at least 12 weeks
- Women in conceptional age: negative pregnancy test and adequate contraception (oral contraceptive, spiral); at men adequate contraception of the man (condom use) to 3 months after discontinuation of therapy with sorafenib
- Histologically or cytologically proven urothelial carcinoma of the bladder or upper urinary tract
- Locally advanced or metastatic urothelial carcinoma of the bladder or upper urinary tract (T3b,T4/ N+/M+)
- At least one unidimensional measurable lesion on CT(Computed Tomography) or MRI(Magnetic resonance imaging) according to RECIST(Response Evaluation Criteria in Solid Tumors) criteria
- Adequate hematologic, renal, hepatic and coagulation-physiological functions

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Exclusion Criteria

- Absence of the above inclusion criteria
- Dialysis after nephrectomy
- Patients with brain tumors and / or brain metastases
- Previous or existing serious cardiovascular (grade III - IV according to NYHA(New York Heart Association)) disease, active angina pectoris or ischemia, myocardial infarction within 6 months prior to enrollment, or patients with serious cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers and digoxin are permitted)
- Patients with uncontrolled high blood pressure, systolic blood pressure> 150 mm Hg or diastolic pressure> 90 mmHg despite optimal medical treatment
- Patients with thrombotic or embolic events such as stroke or pulmonary embolism
- Patients with recently or known bleeding diathesis
- Known significant neurological or psychiatric diseases including dementia and epileptic seizures
- Serious inflammatory eye disease, hearing impairment
- Pulmonary (pO2(Blood oxygen) <60 mm Hg(Millimeters of mercury)), hematopoietic (eg(exempli gratia) severe bone marrow aplasia), hepatic or renal disease
- Patients with poorly controlled diabetes mellitus
- Serious bacterial or fungal infections(>Grade 2 NCI-CTC(National Cancer Institute-Common Terminology Criteria) Version 3)
- chronic hepatitis B or C, HIV(human immunodeficiency virus) infection
- Autoimmune disease

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Ltd. Oberärztin der Klinik u. Poliklinik für Urologie, Kinderurologie und urologische Onkologie Universitätsklinikum Essen
    • Ms.  Prof. Dr.  Susanne  Krege 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Ltd. Oberärztin der Klinik u. Poliklinik für Urologie, Kinderurologie und urologische Onkologie Universitätsklinikum Essen
    • Ms.  Prof. Dr.  Susanne  Krege 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Bayer Vital GmbH
    • Mr. 
    • Gebäude K56
    • 51368  Leverkusen
    • Germany
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    •   0214 / 30-1
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Status

  •   Recruiting stopped after recruiting started
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • Krankenhaus Maria-Hilf
    • Ms.  Prof. Dr.  Susanne  Krege 
    • Dießemer Bruch 80
    • 47805  Krefeld
    • Germany
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  • Further contact 
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    • [---]*
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    •   [---]*
    •   [---]*
    •   [---]*
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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* This entry means the parameter is not applicable or has not been set.