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SNCTP000003799 | NCT03377491 | BASEC2017-02012

PANOVA-3 : Étude pivot, randomisée, en ouvert, portant sur les champs de traitement de la tumeur (TTFields, 150 kHz) en association avec l’administration de gemcitabine et de nab-paclitaxel dans le cadre d’un traitement de première ligne contre l’adénocarcinome du pancréas localement avancé

Datenbasis: BASEC (Import vom 22.09.2021), WHO (Import vom 18.04.2021)
Geändert: 28.03.2021
Krankheitskategorie: Bauchspeicheldrüsenkrebs

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Il s’agit d’une étude ouverte randomisée (1:1), avec deux bras. L’étude a pour objectif
d’étudier si l’ajout de champs TTFields, appliqués au moyen du système NovoTTF-100L(P),
à l’administration de gemcitabine et de nab-paclitaxel dans le cadre d’un traitement de
première ligne chez des patients atteints d’un cancer du pancréas localement avancé et
non résécable, améliore de façon significative les résultats cliniques des patients, par
rapport au traitement par chimiothérapie seule.
Il est prévu qu’environ 556 patients âgés de 18 ans et plus ayant reçu un diagnostic de
cancer du pancréas localement avancé participent à cette recherche aux États-Unis, au
Canada, en Israël et en Europe. Cette étude devrait durer 48 mois. La durée prévue de la
participation de chaque patient est de 10 mois environ.

Untersuchte Krankheiten (Datenquelle: BASEC)

l’adénocarcinome du pancréas localement avancé

Health conditions (Datenquelle: WHO)

Pancreas Adenocarcinoma

Seltene Krankheit (Datenquelle: BASEC)


Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

le traitement du cancer du pancréas avec une chimiothérapie standard (gemcitabine et nab-paclitaxel) en association avec des champs TTFields ou avec une chimiothérapie standard (gemcitabine et nab-paclitaxel) seule

Interventions (Datenquelle: WHO)

Device: NovoTTF-100L(P);Drug: Gemcitabine;Drug: nab paclitaxel

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

1. 18 ans et plus
2. Diagnostic histologique/cytologique d’adénocarcinome du pancréas de novo
3. Maladie localement avancée et non résécable

Ausschlusskriterien (Datenquelle: BASEC)

1. Traitement palliatif antérieur de la tumeur (par ex., chirurgie, radiothérapie)
2. Cancer nécessitant un traitement antitumoral au cours des 5 ans précédant l’inclusion
3. Comorbidités graves

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion Criteria:

1. 18 years of age and older

2. Life expectancy of = 3 months

3. Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas

4. Unresectable, locally advanced stage disease according to the following criteria:

- Head/uncinate process:

1. Solid tumor contact with SMA>180°

2. Solid tumor contact with the CA>180°

3. Solid tumor contact with the first jejunal SMA branch

4. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t
tumor or bland thrombus)

5. Contact with most proximal draining jejunal branch into SMV

- Body and tail

1. Solid tumor contact of >180° with the SMA or CA

2. Solid tumor contact with the CA and aortic involvement

3. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t
tumor or bland thrombus)

- No distant metastasis, including non-regional lymph node metastasis

- No borderline resectable (per Al-Hawary MM, et al., Radiology 201414)

5. ECOG score 0-2

6. Amenable and assigned by the investigator to receive therapy with gemcitabine and

7. Able to operate the NovoTTF-100L(P) System independently or with the help of a

8. Signed informed consent form for the study protocol

Exclusion Criteria:

1. Prior palliative treatment (e.g. surgery, radiation) to the tumor

2. Cancer requiring anti-tumor treatment within the 5 years before inclusion, excluding
treated stage I prostate cancer, in situ cervical or uterus cancer, in situ breast
cancer and non-melanomatous skin cancer.

3. Serious co-morbidities:

1. Clinically significant (as determined by the investigator) hematological, hepatic
and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet
count < 100 x 10^9/L; bilirubin > 1.5 x Upper Limit of Normal (ULN); AST and/or
ALT > 2.5 x ULN; and serum creatinine > 1.5 x ULN.

2. History of significant cardiovascular disease unless the disease is well
controlled. Significant cardiac disease includes second/third degree heart block;
significant ischemic heart disease; poorly controlled hypertension; congestive
heart failure of the New York Heart Association (NYHA) Class II or worse (slight
limitation of physical activity; comfortable at rest, but ordinary activity
results in fatigue, palpitation or dyspnea).

3. History of arrhythmia that is symptomatic or requires treatment. Patients with
atrial fibrillation or flutter controlled by medication are not excluded from
participation in the trial.

4. History of cerebrovascular accident (CVA) within 6 months prior to randomization
or that is not stable.

5. Active infection or serious underlying medical condition that would impair the
ability of the patient to receive protocol therapy.

6. History of any psychiatric condition that might impair patient's ability to
understand or comply with the requirements of the study or to provide consent.

4. Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel

5. Implantable electronic medical devices in the torso, such as pacemakers

6. Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the
chemotherapies used in this trial.

7. 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

8. Unable to follow the protocol for medical, psychological, familial, geographic or
other reasons.

9. Admitted to an institution by administrative or court order.

Weitere Angaben zur Studie im WHO-Primärregister


Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)


Weitere Informationen zur Studie

Registrationsdatum der Studie


Einschluss der ersten teilnehmenden Person




Wissenschaftlicher Titel (Datenquelle: WHO)

Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma

Studientyp (Datenquelle: WHO)


Design der Studie (Datenquelle: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Datenquelle: WHO)

Phase 3

Primäre Endpunkte (Datenquelle: WHO)

Overall survival

Sekundäre Endpunkte (Datenquelle: WHO)

Puncture-free survival;Resectability rate;Toxicity profile;Pain-free survival;Quality of life;One-year survival rate;Objective response rate;Local progression-free survival;Progression-free survival

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar


Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Freiburg, Winterthur

Durchführungsländer (Datenquelle: WHO)

Austria, Canada, Croatia, Czechia, France, Hong Kong, Hungary, Israel, Italy, Poland, Spain, Switzerland, United States

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Dr. Marc Küng

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Antonia Mahnig

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Antonia Mahnig


Hauptsponsor (Datenquelle: WHO)

NovoCure Ltd.

Bewilligung durch Ethikkommission (Datenquelle: BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Commission cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)

Datum der Bewilligung durch die Ethikkommission


Weitere Studienidentifikationsnummern

Studienidentifikationsnummer der Ethikkommission (BASEC-ID) (Datenquelle: BASEC)


Secondary ID (Datenquelle: WHO)