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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03249519
• Other study ID #: HyZer_RCT_IBT
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2017
• Last updated: August 10, 2017
• Start date: August 1, 2017
• Est. completion date: December 31, 2099

Study information

• Verified date: August 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Oliver Ott, MD
• Phone: ++49 9131 85
• Email: st-studiensekretariat[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 999
• Est. completion date: December 31, 2099
• Est. primary completion date: December 31, 2094
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Fever
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Radiation
50.4 Gy
• brachytherapy
35-40 Gy

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

Other:
• Hyperthermia
10 times

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen, Strahlenklinik	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

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