PANOVA-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and nab-paclitael for front-line treatment of locally-advanced pancreatic adenocarcinoma
This study enrolls adults with pancreatic cancer. The purpose of this study is to learn whether an experimental device, a Tumor Treating Fields (TTFields) device called NovoTTF-100L(P), will be safe and effective when used with gemcitabine and nab-paclitaxel (chemotherapy medications typically used to treat this cancer). Tumor Treating Fields (TTFields) are low intensity electric fields delivered with a small medical device. The fields are used on top of area on your body where your cancer is. The purpose is to disrupt the activity of dividing cancer cells.
If you and your doctor decide this study is right for you, you will be randomly assigned (like the flip of a coin) to have standard chemotherapy without the device or chemotherapy and also use the device. If you are in the group that uses the device, you will use it for 18 hours a day throughout your course of chemotherapy. You will come in every 4 weeks for a physical exam and have a CT scan every 8 weeks to check the size of your tumor. Travel expenses may be reimbursed. Study takes place at Kaleida Health's Spindrift Infusion Center in Williamsville, NY.
(CSR 200822692362) PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo pancreatic adenocarcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taanes and have been shown to be additive whe
Adults ages 18+.
Diagnosed with adenocarcinoma of the pancreas (pancreatic cancer).
Interested and assigned by the investigator to have therapy with gemcitabine and nab-paclitaxel.
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