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New treatment option for Pancreatic Cancer
Official title Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
ClinicalTrials.gov ID: NCT04894643
What this study is testing
What is Nab-PACLitaxel?
Nab-PACLitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
Also referred to as Abraxane®.
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
- This is an interventional, single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer.
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
- Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer
- Diagnosis of borderline resectable cancer according to the international consensus definition 2017.
- Negative staging for distant metastasis
- Blood test within the following limits absolute neutrophil count \> 1,500 cells/mm³, platelet count \> 100,000 cells/mm³, Aspartate Aminotransferase...
- Age \> 18 years
You likely can't join if
- Non-exocrine tumors
- Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery
- Presence of distant metastasis
- Pregnancy or unwilling to do adequate conception prevention
- Lactating and unwilling to discontinue lactation
- Men of childbearing potential not willing to use effective means of contraception
See the full eligibility criteria
- Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer
- Diagnosis of borderline resectable cancer according to the international consensus definition 2017.
- Negative staging for distant metastasis
- Blood test within the following limits absolute neutrophil count \> 1,500 cells/mm³, platelet count \> 100,000 cells/mm³, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \ 30 ml/min (as estimated by...
- Age \> 18 years
- Karnofsky index ≥ 70
- No tumor infiltration of stomach or duodenum
- The patient is informed of the diagnosis and is able to give informed consent (Ability of subject to understand character and individual consequences of the study protocol)
- Women of fertile age must have adequate conception prevention measures and must not breast feed
- Signed Informed Consent (must be available before study inclusion)
- Non-exocrine tumors
- Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery
- Presence of distant metastasis
- Pregnancy or unwilling to do adequate conception prevention
- Lactating and unwilling to discontinue lactation
- Men of childbearing potential not willing to use effective means of contraception
- Known allergic/hypersensitivity reaction to any of the components of study treatments
- Previous diagnosis of another neoplasm with worse prognosis as compared with the one in this study
- Metallic prosthesis or other condition that prevent an adequate imaging for target volume definition
- Loco-regional conditions that contraindicate radiotherapy e.g. active infections in the area
- Previous abdominal radiotherapy
- Prior systemic treatment for pancreatic cancer
- Hypersensitivity to PACLitaxel, albumin, gemcitabine or to any of the excipients of the chemotherapy
- Severe hepatic impairment
- Baseline Neutrophil Counts \< 1.5 x 10\^9/L
- Baseline Grade ≥ 2 sensory or motor neuropathy
- Patient refusal
The study team makes the final eligibility decision.
Where it's taking place
- Wiener Neustadt, Lower Austria, Austria
- Wiener Neustadt, Austria
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 Wiener Neustadt, Lower Austria, Austria; Wiener Neustadt, Austria. 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.