Clinical Trial TitleENGOT-ov50/ INNOVATE-3, EF-28: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 200kHz) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer
National Clinical Trial Number:NCT03940196
Clinical Trial Protocol Description:
Since standard treatment (chemotherapy alone) doesn't work well for the treatment of ovarian cancer that has progressed, doctors may recommended patients consider participating in this clinical study.
This study is using an investigational medical device. The term “investigational” means that it is not approved by the U.S Food and Drug Administration (FDA) for use in treating patients, but can be used in research studies like this to see if it is safe and effective. The device, called the NovoTTF100-L (O) System, produces low intensity electric fields called Tumor Treating Fields (TTFields). TTFields are a type of low intensity electric fields delivered using a small medical device. The fields are directed to the region in your body where your cancer is, and are intended to kill dividing cancer cells.
The purpose of this study is to compare using TTFields together with a standard of care chemotherapy drug (called Paclitaxel) to standard of care chemotherapy (Paclitaxel) without TTFields. This study will help the study doctor find out if using TTFields with chemotherapy is better than the usual approach of chemotherapy alone. Study doctors will be looking to see if the addition of TTFields increases life expectancy of patients compared to the usual approach. The study will also look at side effects of TTFields with chemotherapy. Paclitaxel is a drug that is FDA-approved for the treatment of ovarian cancer.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis.
- Have had maximum two prior lines of systemic therapy following diagnosis of platinum‐resistance.
- Have had maximum total of 5 prior lines of systemic therapy .
You will be excluded from the study if any of the following criteria apply to you:
- Have primary platinum‐refractory disease (progression per RECIST V1.1 during or within 1 month after first line therapy).
- Have prior disease progression on a weekly paclitaxel for recurrent disease.
- Have known allergies to medical adhesives or hydrogel.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.