Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
Keywords
Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)
Brief summary
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.
Interventions
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.
The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].
Sponsors
The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed and histologically-confirmed PDAC by biopsy * Permanent street address * Consent to study participation * Axial CT scan consistent with PDAC * No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Exclusion criteria
* Male or female patients \< 18 years of age * No permanent street address or telephone number * Pregnant patients * Inmates or prisoners * Unable to provide informed consent
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria | 2 months after the initiation of chemotherapy | Using the RECIST criteria, treatment response is categorized as follows: * Complete response (CR): Disappearance of all target lesions * Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started * Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
| 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 | from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first) | Disease is defined as clinical evidence of local or distant recurrence. |
Countries
United States
Contacts
CONTACTAmatullah Alibhai, B.A., M.B.A.
CONTACTNicole Fatheree, B.B.A.
PRINCIPAL_INVESTIGATORNirav Thosani, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed