Brief description of trial (Data source: BASEC)
Wir wollen bei Eierstockkrebs untersuchen, wie wirksam und sicher das Medizinprodukt NovoTTF-200(O) in Verbindung mit einer Standardchemotherapie zur Behandlung von Eierstockkrebs ist.
Health conditions investigated(Data source: BASEC)
Die Studie untersucht Eierstockkrebs.
Health conditions
(Data source: WHO)
Ovarian Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Bei den Tumortherapiefeldern (TTFields) handelt es sich um eine Art Niedrigenergiefelder, die von einem kleinen Medizinprodukt namens NovoTTF-200(O) abgegeben werden. Die Felder sind auf die anatomische Region gerichtet, in der sich der Tumor befindet, und dienen dazu, sich teilende Krebszellen abzutöten. Diese Studie untersucht Eierstockkrebs. Wir machen diese Studie, um die Wirksamkeit und Sicherheit von TTFields zusammen mit der Standardchemotherapie (namens Paclitaxel) im Vergleich zu einer Standardchemotherapie (Paclitaxel) ohne TTFields zu beurteilen.
Interventions
(Data source: WHO)
Device: NovoTTF-100L(O);Drug: Paclitaxel
Criteria for participation in trial
(Data source: BASEC)
teilnehmen zu können, müssen alle folgenden Einschlusskriterien erfüllt sein:
1. 18 Jahre oder älter
2. Anhand einer Epitheluntersuchung histologisch bestätigtes Ovarial-, Peritoneal- oder Eileiterkarzinom zum Zeitpunkt der Diagnose
3. Lebenserwartung von ≥12 Wochen
Exclusion criteria
(Data source: BASEC)
1. Primäre platinrefraktäre Erkrankung (Progression gemäß RECIST V1.1 während oder
innerhalb eines Monats nach Erstlinientherapie)
2. Frühere Krankheitsprogression während wöchentlicher Paclitaxeltherapie wegen
rezidivierender Erkrankung
3. Hirnmetastasen oder leptomeningeale Streuung des Tumors
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
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
-
Further information on trial
Recruitment status
Completed
Academic title
(Data source: WHO)
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
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Overall survival
Secundary end point
(Data source: WHO)
Progression-free survival;Objective response rate;Next progression-free survival;Time to undisputable deterioration in health-related quality of life (HRQoL);Time to first and second subsequent treatment;Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.;Severity and frequency of adverse events
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Bellinzona, Frauenfeld, Zurich
Countries
(Data source: WHO)
Austria, Belgium, Canada, Czechia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Viola Heinzelmann-Schwarz
+41 61 556 58 83
viola.heinzelmann@usb.ch
Contact for general information
(Data source: WHO)
Ignace Vergote, MD
University Hospitals Leuven, Leuven Cancer Institute
Contact for scientific information
(Data source: WHO)
Ignace Vergote, MD
University Hospitals Leuven, Leuven Cancer Institute
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
14.05.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-02347
Secondary ID (Data source: WHO)
EF-28
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