Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiation, brachytherapy, Cisplatin, Hyperthermia.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
Overview
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
- Radiation Radiation
50.4 Gy - Radiation brachytherapy
35-40 Gy - Drug Cisplatin
weekly 40 mg/m\^2 (6cycles) - Other Hyperthermia
10 times
Primary outcome measures
- Overall survival [Time frame: 5 years]
Secondary outcome measures (2)
- Disease free survival (local / distant / overall) [Time frame: 5 years]
- Safety by Toxicity assessment according to NCI CTCAE v4.0 [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Universitätsklinikum Erlangen, Strahlenklinik — Erlangen
Identifiers
NCT: NCT03249519 · HyZer_RCT_IBT