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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Radiation
brachytherapy
Cisplatin
Hyperthermia
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Radiation therapy, Chemoradiation, Brachytherapy, Hyperthermia, Cervical cancer, Multimodality treatment of advanced cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Erlangen, StrahlenklinikRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Standard Arm

Arm Description

Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Disease free survival (local / distant / overall)
Safety by Toxicity assessment according to NCI CTCAE v4.0

Full Information

First Posted
August 10, 2017
Last Updated
August 10, 2017
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03249519
Brief Title
Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
Official Title
Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 31, 2094 (Anticipated)
Study Completion Date
December 31, 2099 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Radiation therapy, Chemoradiation, Brachytherapy, Hyperthermia, Cervical cancer, Multimodality treatment of advanced cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
999 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm
Arm Type
Experimental
Arm Description
Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times
Intervention Type
Radiation
Intervention Name(s)
Radiation
Other Intervention Name(s)
Radiation therapy
Intervention Description
50.4 Gy
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Other Intervention Name(s)
Interstitial brachytherapy
Intervention Description
35-40 Gy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
weekly 40 mg/m^2 (6cycles)
Intervention Type
Other
Intervention Name(s)
Hyperthermia
Intervention Description
10 times
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease free survival (local / distant / overall)
Time Frame
5 years
Title
Safety by Toxicity assessment according to NCI CTCAE v4.0
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Ott, MD
Phone
++49 9131 85
Ext
33968
Email
st-studiensekretariat@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Fietkau, MD
Phone
++49 9131 85
Ext
33968
Email
st-studiensekretariat@uk-erlangen.de
Facility Information:
Facility Name
Universitätsklinikum Erlangen, Strahlenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Ott, MD
Phone
++49 9131 85
Ext
33968
Email
st-studiensekretariat@uk-erlangen.de

12. IPD Sharing Statement

Learn more about this trial

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

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