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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Recruiting

CT.gov ID

NCT03249519

Collaborator

(none)

999

Enrollment

Location

Arm

989

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Radiation: Radiation Radiation: brachytherapy Drug: Cisplatin Other: Hyperthermia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

999 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2094

Anticipated Study Completion Date :

Dec 31, 2099

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard Arm Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times	Radiation: Radiation 50.4 Gy Other Names: Radiation therapy Radiation: brachytherapy 35-40 Gy Other Names: Interstitial brachytherapy Drug: Cisplatin weekly 40 mg/m^2 (6cycles) Other: Hyperthermia 10 times

Arm

Intervention/Treatment

Experimental: Standard Arm

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

Radiation: Radiation

50.4 Gy

Other Names:

Radiation therapy

Radiation: brachytherapy

35-40 Gy

Other Names:

Interstitial brachytherapy

Drug: Cisplatin

weekly 40 mg/m^2 (6cycles)

Other: Hyperthermia

10 times

Outcome Measures

Primary Outcome Measures

Overall survival [5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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