Last updated: April 24, 2024
Sponsor: EBG MedAustron GmbH
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pancreatic Cancer
Pancreatic Disorders
Cancer
Treatment
Capecitabine
Gemcitabine
Nab-PACLitaxel
Clinical Study ID
NCT04894643
PARC-MA-062019
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer
- Diagnosis of borderline resectable cancer according to the international consensusdefinition 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 AlanineAminotransferase (ALT) < 2.5 times the upper limit of normal, total bilirubin < 2.5times the upper limit of normal if patient had recent biliary stenting, totalbilirubin < 1.5 times the upper limit of normal if no biliary stenting was done, serumcreatinine within normal range (0.6-1.5 mg/dl) with a creatinine clearance > 30 ml/min (as estimated by Cockroft Gault equation)
- 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 (Abilityof subject to understand character and individual consequences of the study protocol)
- Women of fertile age must have adequate conception prevention measures and must notbreast feed
- Signed Informed Consent (must be available before study inclusion)
Exclusion
Exclusion Criteria:
- 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 onein this study
- Metallic prosthesis or other condition that prevent an adequate imaging for targetvolume definition
- Loco-regional conditions that contraindicate radiotherapy e.g. active infections inthe area
- Previous abdominal radiotherapy
- Prior systemic treatment for pancreatic cancer
- Hypersensitivity to PACLitaxel, albumin, gemcitabine or to any of the excipients ofthe chemotherapy
- Severe hepatic impairment
- Baseline Neutrophil Counts < 1.5 x 10^9/L
- Baseline Grade ≥ 2 sensory or motor neuropathy
- Patient refusal
Study Design
Total Participants: 10
Treatment Group(s): 5
Primary Treatment: Capecitabine
Phase:
Study Start date:
September 14, 2020
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
EBG MedAustron GmbH
Wiener Neustadt, Niederösterreich 2700
AustriaActive - Recruiting
Department of Surgery, LK Wiener Neustadt
Wiener Neustadt, 2700
AustriaActive - Recruiting
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