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

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Radiation: Radiation; Radiation: brachytherapy; Drug: Cisplatin; Other: Hyperthermia

• Registration Number: NCT03249519
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-01
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Last Update Submitted: 2017-08-10
• Study First Posted: 2017-08-15
• Last Update Posted: 2017-08-15
• Primary Completion: 2094-12-31
• Study Completion: 2099-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 999

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Arm	Radiation	Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m\^2 (6 cycles) Hyperthermia: 10 times
Standard Arm	brachytherapy	Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m\^2 (6 cycles) Hyperthermia: 10 times
Standard Arm	Hyperthermia	Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m\^2 (6 cycles) Hyperthermia: 10 times
Standard Arm	Cisplatin	Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m\^2 (6 cycles) Hyperthermia: 10 times

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Erlangen, Strahlenklinik; 🇩🇪 Erlangen, Germany