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

NCT ID: NCT03249519

Last Updated: 2017-08-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

999 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2099-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Radiation

Intervention Type RADIATION

50.4 Gy

brachytherapy

Intervention Type RADIATION

35-40 Gy

Cisplatin

Intervention Type DRUG

weekly 40 mg/m\^2 (6cycles)

Hyperthermia

Intervention Type OTHER

10 times

Interventions

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Radiation

50.4 Gy

Intervention Type RADIATION

brachytherapy

35-40 Gy

Intervention Type RADIATION

Cisplatin

weekly 40 mg/m\^2 (6cycles)

Intervention Type DRUG

Hyperthermia

10 times

Intervention Type OTHER

Other Intervention Names

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Radiation therapy Interstitial brachytherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Oliver Ott, MD

Role: CONTACT

++49 9131 85 ext. 33968

Rainer Fietkau, MD

Role: CONTACT

++49 9131 85 ext. 33968

Facility Contacts

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Oliver Ott, MD

Role: primary

++49 9131 85 ext. 33968

Other Identifiers

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HyZer_RCT_IBT

Identifier Type: -

Identifier Source: org_study_id

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