Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3)
Completed · Phase 3
Conditions studied: Ovarian Cancer
In brief
The 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 . The device 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.
Key facts
- Study ID
- NCT03940196
- Run by
- NovoCure Ltd.
- People needed
- 540
- Starts
- 2019-03-22
- Expected to finish
- 2023-05-18
- Last updated by the study team
- 2024-03-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age and older
- Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis
- Life expectancy of ≥ 12 weeks
- Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance
- Maximum total of 5 prior lines of systemic therapy
- Amenable to receive weekly paclitaxel and able to operate the NovoTTF-100L(O) System
- ECOG 0-1
- Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.
- Signed informed consent form for the study protocol
You may not qualify if…
- Primary platinum-refractory disease (progression per RECIST V1.1 during or within 1 month after first line therapy), while secondary platinum-refractory disease is allowed
- Prior disease progression on a weekly paclitaxel for recurrent disease
- Brain metastasis or leptomeningeal spread of the tumor
- Albumin level <25 gram/liter (subjects should not receive total parenteral nutrition or albumin within 2 weeks of the test)
- CTCAE V5.0 Grade 3 or higher peripheral neuropathy
- Implantable electrical medical devices
- Known allergies to medical adhesives or hydrogel
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to paclitaxel or drugs similar or related to paclitaxel, except for cases that were able to undergo desensitization per investigator
- 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, breast or cervix of the uterus
- Serious co-morbidities
- Concurrent anti-tumor therapy beyond weekly paclitaxel, excluding hormonal therapy for breast cancer
- Concurrent active treatment in another clinical trial. However prior participation in clinical trials is allowed as well as participation during survival follow-up
- Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator
- Admitted to an institution by administrative or court order
Where it is running
- Arizona Oncology — Tucson, Arizona, United States
- University of California — La Jolla, California, United States
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
- California Pacific Medical Center- Pacific Campus — San Francisco, California, United States
- Olive View - UCLA Medical Center — Sylmar, California, United States
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States
- University of Colorado Denver — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers — Boulder, Colorado, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
- Rocky Mountain Cancer Centers — Littleton, Colorado, United States
- Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States
- Rocky Mountain Cancer Centers — Longmont, Colorado, United States
- Rocky Mountain Cancer Centers — Parker, Colorado, United States
- Rocky Mountain Cancer Centers — Pueblo, Colorado, United States
- Rocky Mountain Cancer Centers — Thornton, Colorado, United States
- Broward Health Medical Center — Fort Lauderdale, Florida, United States
- AdventHealth Cancer Institute — Orlando, Florida, United States
- Northeast Georgia Medical Center — Gainesville, Georgia, United States
- Rush University Cancer Center - Chicago and Innovation — Chicago, Illinois, United States
- Des Moines Oncology Research Association — Des Moines, Iowa, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- Arizona Oncology- Biltmore Cancer Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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