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Chemotherapy

TTFields + Chemotherapy for Pancreatic Cancer

Phase 3
Waitlist Available
Research Sponsored by NovoCure Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age and older
Solid tumor contact with the first jejunal SMA branch
Must not have
Prior palliative treatment to the tumor
Cancer requiring anti-tumor treatment within the 5 years before inclusion, excluding specific types of cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new cancer treatment that uses electric fields to kill tumor cells. The treatment is given with gemcitabine and nab-paclitaxel, and is being tested to see if it is safe and effective.

Who is the study for?
This trial is for adults with a new diagnosis of pancreatic adenocarcinoma that can't be surgically removed. They should have a life expectancy of at least 3 months, an ECOG score of 0-2 indicating they are relatively active, and must be able to use or have help using the NovoTTF-200T System. People who've had certain other cancers or treatments in the past 5 years, serious health issues, implanted electronic devices in their torso, severe allergies to adhesives or hydrogel, pregnant women, and those unable to follow the study plan cannot join.
What is being tested?
The PANOVA-3 trial is testing how well Tumor Treating Fields (TTFields) work alongside chemotherapy drugs gemcitabine and nab-paclitaxel in treating advanced pancreatic cancer. TTFields involves wearing a device that delivers electric fields aimed at disrupting cancer cell growth.
What are the potential side effects?
Possible side effects include skin irritation beneath device electrodes, fatigue from carrying the device around as it's battery-operated and worn continuously. Chemotherapy may cause nausea, hair loss, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My tumor is touching the first branch of the jejunal artery.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I am assigned to receive gemcitabine and nab-paclitaxel therapy.
Select...
My condition cannot be treated with surgery and is in an advanced local stage.
Select...
I have been diagnosed with a new case of pancreatic cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received treatment to ease symptoms caused by my tumor.
Select...
I have needed cancer treatment in the last 5 years, not including certain cancers.
Select...
I do not have serious health issues unrelated to my cancer that would prevent me from safely participating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Pain-free survival
Quality of life
Toxicity profile

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Dyspnoea
1%
Cerebral infarction
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NovoTTF-200TExperimental Treatment3 Interventions
Patients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel
Group II: Best Standard of CareActive Control2 Interventions
Patients receive best standard of care with gemcitabine and nab-Paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab paclitaxel
2018
Completed Phase 3
~760
NovoTTF-200T
2018
Completed Phase 3
~850
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

NovoCure Ltd.Lead Sponsor
63 Previous Clinical Trials
5,504 Total Patients Enrolled

Media Library

Gemcitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03377491 — Phase 3
Pancreatic Adenocarcinoma Research Study Groups: NovoTTF-200T, Best Standard of Care
Pancreatic Adenocarcinoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03377491 — Phase 3
Gemcitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03377491 — Phase 3
Pancreatic Adenocarcinoma Patient Testimony for trial: Trial Name: NCT03377491 — Phase 3
~73 spots leftby Dec 2025
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