Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer
CLOSED TO ENROLLMENT
This study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of tumor treating fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer.
NCT03940196
About
Protocol Description
This study is a pivotal, randomized (1:1), open-label, two-arm, multicenter study of the NovoTTF-100L(O) system. The NovoTTF-100L(O) system is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Specifically, it is meant for the treatment of female patients aged 18 years or older with platinum-resistant ovarian, primary peritoneal, or fallopian tube carcinomas, in combination with weekly paclitaxel. It is intended to be used for at least 18 hours per day on a monthly average and exclusively by patients in a clinical trial.
Eligibility Criteria
Inclusion Criteria
- Female patients at least 18 years of age
- Patients with epithelial histology of ovarian, primary peritoneal, or fallopian tube carcinoma at the time of diagnosis
- Patients with a maximum of two prior lines of systemic therapy following diagnosis of platinum-resistance
- Patients with a maximum total of five prior lines of systemic therapy
Exclusion Criteria
- Patients with prior disease progression on a weekly paclitaxel for recurrent disease
- Patients with brain metastasis or leptomeningeal spread of the tumor
- Patients with an implantable electronic medical device in the torso
- Patients with known allergies to medical adhesives or hydrogel
- Patients with prior malignancies treated primarily or for recurrence within 2 years prior to inclusion in this study, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma of the skin or cervix of the uterus
Primary Investigator
Gynecology Oncology provider at Carilion Clinic Gynecological Oncology
Contact Information
Danielle Mitchell, B.S.
Clinical Research Coordinator
