Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05776524
Status:
SUSPENDED
Last Update Posted:
2024-06-14
First Post:
2023-03-08
Brief Title:
Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
Status:
SUSPENDED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Suspending during agreement negotiations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this research is to find out what effects good and bad the combination of gemcitabine and nab-paclitaxel therapy GEM-ABR for the rest of the document standard chemotherapy for pancreatic cancer and the TheraBionic device has on participants condition
Detailed Description:
Primary Objectives The primary objective of this study is to evaluate the efficacy of the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields in improving 6-month overall survival OS rates in patients with metastatic adenocarcinoma of the pancreas
Secondary Objectives
Evaluate the safety and tolerability of the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields in patients with metastatic adenocarcinoma of the pancreas
Evaluate progression-free survival PFS according to Response Evaluation Criteria in Solid Tumors RECIST 11 guidelines in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields
Evaluate the objective response rate ORR in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields
Evaluate the disease control rate DCR in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields
Secondary Objectives
Evaluate the safety and tolerability of the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields in patients with metastatic adenocarcinoma of the pancreas
Evaluate progression-free survival PFS according to Response Evaluation Criteria in Solid Tumors RECIST 11 guidelines in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields
Evaluate the objective response rate ORR in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields
Evaluate the disease control rate DCR in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel gemcitabine and amplitude-modulated radiofrequency electromagnetic fields
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WFBCCC 57122 | OTHER | Wake Forest Baptist Comprehensive Cancer Center | None |