ENGOT-ov50 / GOG-3029 / INNOVATE-3: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 107
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:
The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo ovarian carcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with other chemotherapies. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In a pilot study, 31 patients with recurrent platinum-resistant ovarian carcinoma received paclitaxel together with TTFields (200 kHz) applied to the abdomen/pelvis until disease progression. The combination was well tolerated and the only device-related adverse event was contact dermatitis.
In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life.
DESCRIPTION OF THE TRIAL:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V
- •Signed informed consent form for the study protocol
排除标准
- •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
研究组 & 干预措施
NovoTTF-100L(O)
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
干预措施: NovoTTF-100L(O) (Device)
NovoTTF-100L(O)
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
干预措施: Paclitaxel (Drug)
Best Standard of Care
Patients receive best standard of care with weekly Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall survival
时间窗: 4 years
次要结局
- Progression-free survival(4 years)
- Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.(4 years)
- Objective response rate(4 years)
- Next progression-free survival(4 years)
- Time to first and second subsequent treatment(4 years)
- Severity and frequency of adverse events(4 years)
- Time to undisputable deterioration in health-related quality of life (HRQoL)(4 years)