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

Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03249519

Enrollment

999

Registered

2017-08-15

Start date

2017-08-01

Completion date

2099-12-31

Last updated

2017-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Radiation therapy, Chemoradiation, Brachytherapy, Hyperthermia, Cervical cancer, Multimodality treatment of advanced cervical cancer

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.

Interventions

DRUGCisplatin

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

OTHERHyperthermia

10 times

RADIATIONbrachytherapy

35-40 Gy

RADIATIONRadiation

50.4 Gy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Overall survival	5 years

Secondary

Measure	Time frame
Disease free survival (local / distant / overall)	5 years
Safety by Toxicity assessment according to NCI CTCAE v4.0	5 years

Countries

Germany

Contacts

Primary ContactOliver Ott, MD

st-studiensekretariat@uk-erlangen.de++49 9131 85

Backup ContactRainer Fietkau, MD