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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA277161-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) | Device | Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) consists of the application of an alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor; which induces the release of large amounts of cellular debris. This cellular debris represents a source of tumor antigens that can trigger a host adaptive immune response against the tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection | From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria | Using the RECIST criteria, treatment response is categorized as follows:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia C Colon, BS | Contact | 713-500-6658 | Sofia.C.Colon@uth.tmc.edu | |
| Nirav Thosani, MD | Contact | 713-486-1350 | pancreasresearch@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nirav Thosani, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Neoadjuvant Chemotherapy (NAC) | Drug | The NAC regimen will be determined clinically by the participant's physician [possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)]. |
|
| 2 months after the initiation of chemotherapy |
| Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria | Using the RECIST criteria, treatment response is categorized as follows:
| 4 months after the initiation of chemotherapy |
| Number of participants with post-operative complications | from the time of surgical tumor resection to 90 days following surgical tumor resection |
| Disease-free survival time | Disease is defined as clinical evidence of local or distant recurrence. | from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first) |
| D003131 |
| Combined Modality Therapy |
| D013812 | Therapeutics |