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New treatment option for Cervical Cancer
Official title Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT03249519
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Erlangen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erlangen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.