Status:
RECRUITING
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Lead Sponsor:
EBG MedAustron GmbH
Collaborating Sponsors:
Landesklinkum Wiener Neustadt
Conditions:
Pancreatic Cancer
Proton Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
This is an interventional, single arm, open label, feasibility trial of preoperative chemotherapy + concomitant chemo-proton therapy followed by surgery (when feasible) for patients with borderline re...
Eligibility Criteria
Inclusion
- 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) \< 2.5 times the upper limit of normal, total bilirubin \< 2.5 times the upper limit of normal if patient had recent biliary stenting, total bilirubin \< 1.5 times the upper limit of normal if no biliary stenting was done, serum creatinine 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 (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)
Exclusion
- 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
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04894643
Start Date
September 14 2020
End Date
December 31 2027
Last Update
May 8 2025
Active Locations (2)
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1
EBG MedAustron GmbH
Wiener Neustadt, Lower Austria, Austria, 2700
2
Department of Surgery, LK Wiener Neustadt
Wiener Neustadt, Austria, 2700