Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE)
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|ClinicalTrials.gov Identifier: NCT02244502|
Recruitment Status : Unknown
Verified July 2016 by NovoCure Ltd..
Recruitment status was: Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : September 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Carcinoma||Device: NovoTTF-100L(O) Drug: Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Pilot Study of the NovoTTF-100L(O) System (NovoTTF Therapy) (200 kHz) Concomitant With Weekly Paclitaxel for Recurrent Ovarian Carcinoma|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: TTFields in combination with weekly paclitaxel
Patients will be treated continuously with the NovoTTF-100L(O) device, in addition to weekly paclitaxel.
Patients will be treated continuously with the NovoTTF-100L(O). NovoTTF-100L(O) treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Paclitaxel 80 mg/m2 over 1 hour infusion will be administered weekly for 8 weeks and then on days 1, 8, 15 of each subsequent 28 day cycle.
Other Name: Taxol
- Adverse Events Severity and Frequency [ Time Frame: 1.5 years ]
- Number of patients prematurely discontinuing TTFields due to Skin Toxicity [ Time Frame: 1.5 yeras ]
- Progression Free Survival [ Time Frame: 1.5 years ]
- Overall Survival [ Time Frame: 1.5 years ]
- 1 Year Survival Rate [ Time Frame: 1.5 years ]
- Overall Radiological Response Rate and Duration of Response [ Time Frame: 1.5 years ]
- CA-125 Response Rate and Duration of Response [ Time Frame: 1.5 years ]
- Patients' compliance with TTFields Therapy [ Time Frame: 1.5 years ]Patient compliance will be assessed by evaluating the device log file which will be downloaded every 4 weeks from the NovoTTF-100L(O) System. Compliance will be presented as an hourly average over a 24 hour period during the 4 weeks and as an average percentage of use over the 4 week period.
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): NCT02244502
|Charité - Universitätsmedizin Berlin|
|Hospitale Universitario 12 de Octubre|
|Ospedale San Giovanni|
|Principal Investigator:||Cristina Sessa, MD||Ospedale San Giovanni|