Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
NCT ID: NCT03249519
Last Updated: 2017-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
999 participants
INTERVENTIONAL
2017-08-01
2099-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Standard Arm
Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m\^2 (6 cycles) Hyperthermia: 10 times
Radiation
50.4 Gy
brachytherapy
35-40 Gy
Cisplatin
weekly 40 mg/m\^2 (6cycles)
Hyperthermia
10 times
Interventions
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Radiation
50.4 Gy
brachytherapy
35-40 Gy
Cisplatin
weekly 40 mg/m\^2 (6cycles)
Hyperthermia
10 times
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FIGO-Stage IIB-IVA; earlier stages when inoperable or according to patient's wish
* clinical M0; except: involvement of para-aortic lymph nodes
* Age ≥ 18 years
* ECOG ≤ 2
* Informed consent of the patient
Exclusion Criteria
* 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 chemoradiation or deep regional hyperthermia
* Metal implants (length \> 2cm or dense clusters of marker clips in the pelvis)
* Active or therapy-resistent bladder infections
* Pre-existing or concommitant immunodeficiency Syndrome
* Pregnant or lactating women
* Patients not willing to use effective contraception during and up to 6 months after therapy
18 Years
FEMALE
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Locations
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Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HyZer_RCT_IBT
Identifier Type: -
Identifier Source: org_study_id
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