CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 571 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² on days 1, 8, and 15 of each 28-day cycle, with continuous NovoTTF-200T device treatmentAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed de novo adenocarcinoma of the pancreas
  • ✓Unresectable, locally advanced disease with tumor-vessel involvement meeting specific anatomical criteria (SMA/CA contact >180° or vascular involvement) and no distant metastases
  • ✓Age ≥18 years with life expectancy ≥3 months
  • ✓ECOG performance status 0-2
Key exclusion· 9
  • ✕Prior palliative surgery or radiation to the pancreatic tumor
  • ✕Any active malignancy or cancer requiring anti-tumor treatment within 5 years (excluding treated stage I prostate cancer, in situ cervical/uterine/breast cancer, and non-melanomatous skin cancer)
  • ✕Implantable electronic medical devices in the torso (pacemakers, etc.)
  • ✕Severe hypersensitivity to medical adhesives, hydrogel, or study chemotherapy drugs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03377491
NCT03377491Phase 3Completed
CompareCT.gov

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

NovoCure Ltd.·interventional·Posted Dec 19, 2017·Updated Jan 21, 2026

In Brief

A Phase 3 clinical trial evaluating NovoTTF-200T, Gemcitabine, and 1 other intervention for Pancreas Adenocarcinoma. Completed, enrolled 571 participants across 199 sites in 20 countries.

Detailed Summary

Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreas Adenocarcinoma
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Poland, South Korea, Spain, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 19, 2017
Enrollment StartMay 10, 2018
Primary CompletionOct 16, 2024
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 8.5 years ago

Interventions

NovoTTF-200Tdevice

Patients receive continuous TTFields treatment using the NovoTTF-200T device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.

Gemcitabinedrug

Gemcitabine 1000 mg/m\^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.

nab paclitaxeldrug

nab-paclitaxel 125 mg/m\^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.