RecruitingPhase 2NCT05624918

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

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

Sponsor

Ashish Manne

Enrollment

38 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Adenocarcinoma Resectable Pancreatic Cancer

Summary

This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a device called NovoTTF-200T(P) — which uses electrical fields to disrupt cancer cell division — to standard pre-surgery chemotherapy improves outcomes for people with pancreatic cancer that can potentially be surgically removed. **You may be eligible if...** - You are 18 or older with pancreatic adenocarcinoma confirmed by biopsy or cytology - Your cancer is considered surgically removable based on CT or MRI scans - You have not had any prior treatment for pancreatic cancer - Your overall performance is reasonably good (Karnofsky score ≥70%) - Your blood counts, kidney, and liver functions are adequate - HIV-positive patients on effective antiviral therapy with undetectable viral load may be eligible **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (metastatic) - You have an implanted electrical device in your torso (pacemaker, spinal cord stimulator, defibrillator) - You have significant heart disease or poorly controlled high blood pressure - You have a known allergy to medical adhesives or conductive gel (used in ECG patches) - You are pregnant or breastfeeding - You have another active cancer that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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