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New treatment option for Pancreatic Cancer
Official title Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT05776524
What this study is testing
What is Nab paclitaxel?
Nab paclitaxel is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass...
- One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies (CT or MRI) of chest...
- Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of...
- Age 18 years old or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
You likely can't join if
- Patients treated with any chemotherapy in metastatic setting and/or who had chemotherapy with gemcitabine and/or nab-paclitaxel within six months...
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive...
- History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and...
- History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low...
- Patients receiving calcium channel blockers and any agent blocking L-type of T type Voltage Gated Calcium Channels such as amlodipine, nifedipine...
- Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if...
See the full eligibility criteria
- Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic...
- One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies (CT or MRI) of chest, abdomen and pelvis.
- Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6...
- Age 18 years old or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Patients must have organ and marrow function as defined below: Organ and Marrow Function Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets\ ≥ 100,000/mcL Hemoglobin\ ≥ 7 g/dL \ It is acceptable to transfuse packed...
- Patients treated with any chemotherapy in metastatic setting and/or who had chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to entering the study in the adjuvant or neo-adjuvant setting are...
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of...
- History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and nab-paclitaxel.
- History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible.
- Patients receiving calcium channel blockers and any agent blocking L-type of T type Voltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are not allowed in the study unless their medical treatment...
- Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy is...
- Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study...
- Known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or pneumonitis.
- Pregnant women are excluded from this study because of potential risk for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment...
- Localized resectable or locally advanced tumor.
- Undergone surgery, other than diagnostic surgery or minor procedures, within 4 weeks prior to the treatment day.
- Unable to comply with study procedures or anticipating a situation that would result in a treatment break for 14 or more consecutive days after the start of the study.
- Actively enrolled in any other clinical treatment trial or receiving any other investigational agents.
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.