ENGOT-ov50/INNOVATE-3: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant with Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer.
The ENGOT-ov50/INNOVATE-3 is a phase III study conducted globally and will be enrolling 540 participants over the course of 30 months (enrollment period) the total duration of the study is 48 months. Participants will be enrolled after signing the inform consent form and will be assigned randomly (through an electronic statistical system) into 2 groups. The participants assigned to first group will receive treatment with Tumor Treating Fields (TTFields) delivered via medical device plus the standard of care chemotherapy (FDA approved) named Paclitaxel. Participants assigned to group 2 will only receive standard of care chemotherapy (FDA approved) named Paclitaxel. The TTFields will be administered to the participant via a portable, battery operated medical device that is intended to adjust to the participants lifestyle. TTFields are electric forces intended to disrupt cancer cell division. Each participant in the group receiving TTFields treatment will have a Device Support Specialist (DSS) technician assigned to them to provide technical support for the duration of their participation in the clinical study.
4 Key Inclusion/Exclusion Criteria including Age Range If Applicable:
Participants must be 18 years of age or older, must have confirmed histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis, performance status 0-1, life expectancy greater than 12 weeks.
Participants who are pregnant and/or breast feeding are not allowed
Participants with primary platinum-refractory disease are not eligible, while secondary platinum-refractory disease is allowed
Participants with implantable electrical medical devices and/or any known allergies to medical adhesives or hydrogel will be excluded
Participants with concurrent active treatment in another clinical trial will be excluded from this study, however, prior participation in clinical trials is allowed as well as participation during survival follow-up