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Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249519
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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Brief Summary:
The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: Radiation Radiation: brachytherapy Drug: Cisplatin Other: Hyperthermia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 999 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2094
Estimated Study Completion Date : December 31, 2099

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard Arm
Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times
 Radiation: Radiation
50.4 Gy
Other Name: Radiation therapy

Radiation: brachytherapy
35-40 Gy
Other Name: Interstitial brachytherapy

Drug: Cisplatin
weekly 40 mg/m^2 (6cycles)

Other: Hyperthermia
10 times


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease free survival (local / distant / overall) [ Time Frame: 5 years ]
  2. Safety by Toxicity assessment according to NCI CTCAE v4.0 [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmed carcinoma of the Cervix
  • 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:

  • 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249519


Contacts
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Contact: Oliver Ott, MD ++49 9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de
Contact: Rainer Fietkau, MD ++49 9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de

Locations
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Germany
Universitätsklinikum Erlangen, Strahlenklinik Recruiting
Erlangen, Germany, 91054
Contact: Oliver Ott, MD    ++49 9131 85 ext 33968    st-studiensekretariat@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
More Information
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03249519    
Other Study ID Numbers: HyZer_RCT_IBT
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Radiation therapy
Chemoradiation
Brachytherapy
 Hyperthermia
Cervical cancer
Multimodality treatment of advanced cervical cancer
Additional relevant MeSH terms:
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Hyperthermia
Fever
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Cisplatin
Antineoplastic Agents