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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
125 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle
1000 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle
Worn \> 18 hr /day starting C1D1 until completion of cycle 3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITING2 Year Overall Survival (OS)
Determine the two-year OS rate. Two-year (2-Y) OS will be calculated as the percentage of patients who remain alive at the 2 year mark from the registration date.
Time frame: 2 years
Rate of Resection
Determine the rate of resection following the neoadjuvant treatment with TTFields in combination with chemotherapy. Resectability rate will be calculated as the proportion of evaluable patients undergoing R0 or R1 resection following the neoadjuvant segment of therapy.
Time frame: 4 years
Assess adverse events
Assess frequency and severity of adverse events when TTFields is added to gemcitabine and nab-paclitaxel chemotherapy using CTCAE v5 criteria. Adverse Events (AE): AEs and the maximum grade for each type of adverse events will be summarized for each patient separately for the following three periods: * During perioperative therapy * Complications during surgery and post-operative period for 30 days * During adjuvant therapy
Time frame: 3 months, 5 months, and 10 months
Overall Response Rate (ORR)
Determine ORR. Overall response rate will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST v1.1.
Time frame: 4 years
Post Resection Disease Free Survival (DFS)
Estimate the post resection DFS. DFS will be estimated in patients undergoing resection and will be defined as the date of resection to the date of first documentation of recurrence (loco-regional or distant) or death due to any cause.
Time frame: 4 years
Overall Survival (OS)
Estimate the median OS is defined as the time from initiation of therapy to death from any cause. OS will be assessed from date of registration till death from any cause on an intention to treat basis.
Time frame: 4 years
Rate of Major Histological Response
Assess the patterns and rate of major histological response.Pathologic response will be evaluated after the patient has had surgery, and will be based on local pathology review of the resected surgical specimen, according to the following (Treatment effect assessment will be per "College of American Pathology Protocol for the Examination of Specimens From Patients With Carcinoma of the Exocrine Pancreas") Tumor Regression Grade: * 0: Complete response - no residual tumor * 1: Moderate response - minimal residual cancer (single cells or small groups of cancer cells) * 2: Minimal response - residual cancer outgrown by fibrosis * 3: Poor or no response - no definite response identified (minimal or no tumor kill; Extensive residual cancer)
Time frame: 4 years
Patterns of Recurrence
Describe the patterns of recurrence. Pattern of recurrence will be assessed for patients undergoing resection and will be categorized into local vs distant. Loco-regional recurrence will be defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes: * Superior mesenteric artery and vein lymph nodes * Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes) * Lymph nodes around left renal vein, inferior vena cava or aorta * Celiac axis lymph nodes
Time frame: 4 years
Time to Locoregional Recurrence (TLR)
Evaluate TLR. TLR is defined as the time from the date of registration to the date of locoregional recurrence after resection.
Time frame: 4 years
Time to Distant Metastases (TDM)
Evaluate TDM. Time to Distant Metastases (TDM): TDM is defined as the time from the date of registration to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection.
Time frame: 4 years
Chemotherapy relative dose intensity
Chemotherapy relative dose intensity delivered per agent is defined as the total cumulative dose (both perioperative and adjuvant) the patient received divided by total dose planned per protocol, times 100%.
Time frame: 4 years
TTFields Compliance Rate
Evaluate compliance with TTFields. The device will be inspected either by the investigator or by a Novocure representative on a monthly basis to assess patient compliance with therapy. Average number of daily hours will be calculated.
Time frame: 4 years
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