Clinical trial · Interventional
Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA)
A Phase II Study of TTFields (150 kHz) Concomitant With Gemcitabine and TTFields Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is a prospective, double arm, non-randomized, open label pilot trial, designed to study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L concomitant with gemcitabine or concomitant with gemcitabine plus nab-paclitaxel, for front-line therapy of pancreatic adenocarcinoma. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| NovoTTF-100L | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TTFilelds + gemcitabine
- description
- Patients will be treated continuously with the NovoTTF-100L device, in addition to Gemcitabine.
- interventionNames
- Device: NovoTTF-100L
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- TTFields + gemcitabine+ nab-paclitaxel
- description
- Patients will be treated continuously with the NovoTTF-100L device, in addition to Gemcitabine plus nab-paclitaxel
- interventionNames
- Device: NovoTTF-100L
- Drug: Gemcitabine
- Drug: nab-Paclitaxel
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of unresectable locally advanced or metastatic adenocarcinoma of the pancreas with histologically or cytologically confirmed disease. 2. 18 years of age and older 3. Life expectancy of at least 12 weeks 4. Measureable or assessable disease according to the revised RECIST criteria version 1.1. 5. ECOG (Eastern Cooperative Oncology Group) score 0-1 6. Adequate bone marrow, liver and kidney function: 1. Absolute neutrophil count ≥ 1.5 x 10\^9/L 2. Platelet count ≥ 100 x 10\^9/L 3. Hemoglobin ≥ 10 g/dL 4. AST and/or ALT ≤ 3 x upper limit of normal range (ULN) or ≤ 5 x ULN if patient has documented liver metastases 5. Bilirubin ≤1.5 x ULN 6. Serum creatinine ≤ 1.5 x ULN 7. Coagulation status: PT and PTT within normal limits or within therapeutic limits for patients receiving anticoagulation. 7. Able to operate the NovoTTF-100L System independently or with the help of a caregiver. 8. No concurrent anti-tumor therapy (beyond gemcitabine or gemcitabine and nab-paclitaxel and TTField therapy as per protocol). 9. No prior chemotherapy or radiation allowed. 10. At least 4 weeks since major surgery. 11. Prior surgery allowed for local disease provided a measurable lesion remains on the baseline CT scan. 12. Signed informed consent form Exclusion Criteria: 1. Known brain metastases or meningeal carcinomatosis. 2. Any other malignancy requiring anti-tumor treatment in the past three years. 3. Significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy: 1. 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). 2. 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. 3. Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy. 4. History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent. 4. Implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc. 5. Known allergies to medical adhesives or hydrogel or nab-paclitaxel. 6. Pregnant or breast feeding. 7. Admitted to an institution by administrative or court order
References
Publications (7)
- BACKGROUNDKirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083. PMID 15126372
- BACKGROUNDKirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5. PMID 17551011
- BACKGROUNDKirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23. PMID 19387848
- BACKGROUNDPless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9. PMID 21548832
- BACKGROUNDStupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18. PMID 22608262
- BACKGROUNDPless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.