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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)

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ClinicalTrials.gov Identifier: NCT03940196
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Device: NovoTTF-100L(O) Drug: Paclitaxel Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: NovoTTF-100L(O)
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
 Device: NovoTTF-100L(O)
Patients receive continuous TTFields treatment using the NovoTTF-100L(O) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen/pelvis. The treatment enables the patient to maintain regular daily routine.
Other Name: TTFields

Drug: Paclitaxel
Paclitaxel 80 mg/m^2 intravenous infusion will be administered weekly for 8 weeks and then on Days 1, 8 and 15 of each subsequent 28-day cycle.
Other Names:
  • Weekly Paclitaxel
  • Taxol
Active Comparator: Best Standard of Care
Patients receive best standard of care with weekly Paclitaxel
 Drug: Paclitaxel
Paclitaxel 80 mg/m^2 intravenous infusion will be administered weekly for 8 weeks and then on Days 1, 8 and 15 of each subsequent 28-day cycle.
Other Names:
  • Weekly Paclitaxel
  • Taxol


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 4 years ]
  2. Objective response rate [ Time Frame: 4 years ]
  3. Next progression-free survival [ Time Frame: 4 years ]
    Measured from the time of randomization to tumor progression on next-line treatment

  4. Time to undisputable deterioration in health-related quality of life (HRQoL) [ Time Frame: 4 years ]
    Measured as the time interval between randomization until the first decrease in HRQoL score ≥ 10-point with no further improvement in HRQoL score ≥ 10 points on any further HRQoL data, based on the EORTC QLQ-C30 questionnaire

  5. Time to first and second subsequent treatment [ Time Frame: 4 years ]
    Measured as the time from the date of randomization to the clinical decision made by the investigator to initiate a first and second subsequent lines of treatment, respectively, or death date

  6. Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module. [ Time Frame: 4 years ]
  7. Severity and frequency of adverse events [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age and older
  2. Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis
  3. Life expectancy of ≥ 12 weeks
  4. Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance
  5. Maximum total of 5 prior lines of systemic therapy
  6. Amenable to receive weekly paclitaxel and able to operate the NovoTTF-100L(O) System
  7. ECOG 0-1
  8. Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.
  9. Signed informed consent form for the study protocol

Exclusion Criteria:

  1. 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
  2. Prior disease progression on a weekly paclitaxel for recurrent disease
  3. Brain metastasis or leptomeningeal spread of the tumor
  4. Albumin level <25 gram/liter (subjects should not receive total parenteral nutrition or albumin within 2 weeks of the test)
  5. CTCAE V5.0 Grade 3 or higher peripheral neuropathy
  6. Implantable electrical medical devices
  7. Known allergies to medical adhesives or hydrogel
  8. 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
  9. 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
  10. Serious co-morbidities
  11. Concurrent anti-tumor therapy beyond weekly paclitaxel, excluding hormonal therapy for breast cancer
  12. Concurrent active treatment in another clinical trial. However prior participation in clinical trials is allowed as well as participation during survival follow-up
  13. 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
  14. Admitted to an institution by administrative or court order
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940196


Contacts
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Contact: Waleed Shalaby 215-801-3260 WShalaby@novocure.com
Contact: Elizabeth Soward 910-604-2421 ESoward@novocure.com

Locations
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Sponsors and Collaborators
NovoCure Ltd.
Investigators
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Principal Investigator: Ignace Vergote, MD University Hospitals Leuven, Leuven Cancer Institute
More Information
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Publications:

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Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT03940196    
Other Study ID Numbers: EF-28
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by NovoCure Ltd.:
Platinum Resistant Ovarian Cancer
TTFields
Paclitaxel
Minimal toxicity
 TTF
Tumor Treating Fields
Novocure
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action