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Recruiting NCT05679674

Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer

Trial Parameters

Condition Pancreas Cancer
Sponsor Baptist Health South Florida
Study Type INTERVENTIONAL
Phase N/A
Enrollment 48
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-21
Completion 2027-06
Interventions
Stereotactic Ablative Body Radiation (SABR)Tumor Treating Fields (TTF)

Brief Summary

The purpose of this clinical trial is to determine whether using chemotherapy followed by stereotactic ablative body radiation therapy (SABR) and tumor treating fields (TTF) will slow tumor growth in people with locally advanced pancreas cancer. All participants will receive SABR therapy once per day for five days and use the TTF system for at least 18 hours per day starting on the first day of SABR until the tumor progresses or severe toxicity develops.

Eligibility Criteria

Inclusion Criteria: * Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas. Locally advanced pancreas cancer as per National Comprehensive Cancer Network (NCCN) Guidelines. * Regional lymph node involvement is permitted if able to be treated with radiation therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * At least 3 months of prior FOLFIRINOX, modified FOLFIRINOX, and/or gemcitabine/nab-paclitaxel delivered for pancreas cancer without evidence of distant progression on restaging radiographic studies. * Carbohydrate antigen 19-9 (CA 19-9) ≤500 U/mL on most recent assessment prior to study enrollment. * Adequate normal organ and marrow function as defined below: i. Hemoglobin ≥8.0 g/dL that may be achieved with transfusion ii. Absolute neutrophil count (ANC) ≥1500 per mm\^3 iii. Platelet count ≥60,000 per mm\^3 iv. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) v. AST (SGOT)/ALT (SGPT) ≤3 x institut

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