Is NCT06423326 recruiting in Washington Dc, DC?

Yes, NCT06423326 is currently recruiting participants at its Washington Dc, DC location. This borderline resectable pancreatic ductal adenocarcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Washington Dc clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Borderline Resectable Pancreatic Ductal Adenocarcinoma Clinical Trial in Washington Dc, DC

Q: How do I join the borderline resectable pancreatic ductal adenocarcinoma clinical trial in Washington Dc?

To join this clinical trial in Washington Dc, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Borderline Resectable Pancreatic Ductal Adenocarcinoma Study in Washington Dc

This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy is more feasible and could improve outcomes compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.

Sponsor: Emory University

Who Can Participate

Inclusion Criteria

Histologically or cytologically confirmed - resectable and borderline resectable pancreatic ductal adenocarcinoma

Resectability will be defined as per National Comprehensive Cancer Network (NCCN) guidelines using cross-sectional imaging (contrast-enhanced computed tomography or magnetic resonance imaging scans of the abdomen, and pelvis)

Decisions about resectability status will be made in consensus at multidisciplinary meetings/discussions Resectable disease will be defined as:

No interface of the tumor with celiac artery, common hepatic artery (CHA), or superior mesenteric arteries (SMA) (and, if present, variants)

Less than 180° interface between tumor and vessel wall of the portal or superior mesenteric veins (SMV) without vein contour irregularity

For tumors of the body and tail of the pancreas, interface with the splenic artery and splenic vein of any degree will be considered resectable disease Borderline resectable disease will be defined as:

To include at least one of the following:

Tumor abutment \< 180° of the superior mesenteric artery or celiac axis

Solid tumor contact with CHA without extension to celiac artery (CA) or hepatic artery bifurcation allowing for safe and complete resection and reconstruction

Solid tumor contact with variant arterial anatomy (ex: accessory right hepatic artery, replaced right hepatic artery, replaced CHA, and the origin of replaced or accessory artery)

Tumor induced narrowing of SMV, portal vein (PV) or SMV-PV of \> 180˚ of the diameter of the vessel

Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction

Solid tumor contact with inferior vena cava

Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA)

No distant extrapancreatic disease (M0)

Adults \> 18 years of age

Able to give informed consent

Able to adhere to study visit schedule and other protocol requirements

Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

Absolute neutrophil count (ANC) ≥ 1,500 cells/ul

Platelet count ≥ 100,000 cells/ul

Hemoglobin ≥ 9 g/dL

Serum total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

Albumin ≥ 3 g/dl

Creatinine ≤ 1.5 x ULN

Male, or a non-pregnant and non-lactating female

Women of child-bearing potential - defined as a sexually mature woman who has not undergone hysterectomy - the surgical removal of the uterus or bilateral oophorectomy - the surgical removal of both ovaries or has not been naturally postmenopausal for at least 24 consecutive months, i.e., has had menses at any time during the preceding 24 consecutive months, must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel (including dose interruptions) until treatment with gemcitabine/cisplatin/nab-paclitaxel is complete

Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/nab-paclitaxel and for 6 months following gemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has undergone a successful vasectomy

Exclusion Criteria

Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"

Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations

Pregnancy (positive pregnancy test) or lactation

Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery \[RS\]; Gamma Knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded

Previous (within the past 5 years) or concurrent presence of other untreated cancer, except nonmelanoma skin cancer and in situ carcinomas

History of allergy or hypersensitivity to any of the study drugs

Current abuse of alcohol or illicit drugs

Inability or unwillingness to sign the informed consent form

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Washington Dc?

Yes, this clinical trial (NCT06423326) has an active research site in Washington Dc, DC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Borderline Resectable Pancreatic Ductal Adenocarcinoma Treatment Options in Washington Dc, DC

If you're searching for borderline resectable pancreatic ductal adenocarcinoma treatment options in Washington Dc, DC, this clinical trial (NCT06423326) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Washington Dc research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced borderline resectable pancreatic ductal adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all borderline resectable pancreatic ductal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Borderline Resectable Pancreatic Ductal Adenocarcinoma Clinical Trial in Washington Dc, DC

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