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

Study Overview
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: Radiation
* Radiation: brachytherapy
* Drug: Cisplatin
* Other: Hyperthermia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Arm<br>Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times | Radiation: Radiation<br>* 50.4 Gy<br>* Other names: Radiation therapy;Radiation: brachytherapy<br>* 35-40 Gy<br>* Other names: Interstitial brachytherapy;Drug: Cisplatin<br>* weekly 40 mg/m^2 (6cycles)<br>Other: Hyperthermia<br>* 10 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation therapy, Chemoradiation, Brachytherapy, Hyperthermia, Cervical cancer, Multimodality treatment of advanced cervical cancer