← Back to Search

Anti-metabolites

NovoTTF-200T(P) + Chemotherapy for Pancreatic Cancer

Phase 2

Recruiting

Led By Ashish Manne, MD

Research Sponsored by Ashish Manne

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is for patients w/ locally advanced or metastatic pancreatic cancer, who will receive 3 cycles of chemo & TTFields, then surgery, possibly followed by 3 more cycles of chemo.

Who is the study for?

This trial is for adults with resectable pancreatic adenocarcinoma who haven't had prior treatments. They must have a Karnofsky Performance Status of at least 70%, no distant metastasis, and adequate organ function. Women of childbearing potential and men must agree to use contraception.Check my eligibility

What is being tested?

The study tests NovoTTF-200T(P) combined with chemotherapy drugs Gemcitabine and Nab-Paclitaxel in patients with pancreatic cancer. Participants will receive this combination before and after surgery if the tumor can be removed.See study design

What are the potential side effects?

Possible side effects include reactions to adhesives or conductive hydrogel, blood disorders from chemotherapy, fatigue, digestive issues like nausea or diarrhea, skin irritation from TTFields therapy, and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

2 Year Overall Survival (OS)

Rate of Resection

Secondary outcome measures

Assess adverse events

Chemotherapy relative dose intensity

Overall Response Rate (ORR)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational GroupExperimental Treatment3 Interventions

Nab-paclitaxel + gemcitabine + NovoTTF-200T(P) for 3 cycles (28 day cycles) Participants who have stable disease or better after the first 3 cycles of treatment will undergo pancreatectomy within 8 weeks of receiving treatment. If the surgery yields R0 or R1 then patient will receive another 3 cycles of treatment regimen (within 8 weeks of surgery). Those who do not undergo surgery will still be included in the evaluable patients for the objectives

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab paclitaxel

2014

Completed Phase 2

~70

Gemcitabine

2017

Completed Phase 3

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ashish ManneLead Sponsor

NovoCure GmbHIndustry Sponsor

11 Previous Clinical Trials

2,701 Total Patients Enrolled

Ohio State UniversityOTHER

830 Previous Clinical Trials

505,582 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Investigational Group earned the blessing of the Federal Drug Administration?

"We assign a numerical value of 2 to the Investigational Group's safety rating, as this is only Phase 2 and there has yet to be evidence demonstrating efficacy."

Answered by AI

What is the population size of participants in this experiment?

"Affirmative. Evidenced on clinicaltrials.gov, the investigation is actively seeking out qualified individuals and was initially disseminated on October 1st 2023 with a recent update occurring in 4th of that same month. A total of 38 participants are needed from one single site."

Answered by AI

Are there current opportunities for participation in this trial?

"Affirmative. Clinicaltrials.gov demonstrates that this clinical study, which was first published on October 1st 2023, is actively recruiting patients. 38 individuals need to be found from a single medical centre."

Answered by AI

What are the chief aims of this experiment?

"This two-year medical study assesses the Rate of Resection and identifies secondary outcomes such as Assess Adverse Events, Post Resection Disease Free Survival (DFS), and Overall Survival (OS). AE is defined in terms of frequency and severity according to CTCAE v5 criteria. DFS is measured from date of resection until recurrence or death due to any cause, while OS is calculated from date of registration until death from any cause on an intention to treat basis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

Ashish Manne 2024. "A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05624918.