Actively Recruiting
Preoperative Proton Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Led by EBG MedAustron GmbH · Updated on 2026-03-20
10
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
EBG MedAustron GmbH
Lead Sponsor
L
Landesklinkum Wiener Neustadt
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of a combined treatment approach for patients with borderline resectable pancreatic cancer. This interventional, single-arm, open-label trial aims to test referral and enrollment procedures as well as the technical feasibility of delivering preoperative chemotherapy followed by proton therapy combined with chemotherapy and subsequent surgery when possible. The study is conducted due to the complexity of delivering high-dose proton therapy to large abdominal areas and the need for multidisciplinary care in pancreatic cancer patients. Participants will receive three cycles of chemotherapy with Nab-PACLitaxel and Gemcitabine, administered intravenously over 30 minutes on days 1, 8, and 15 of each cycle. This is followed by proton therapy delivered with a simultaneous integrated boost (SIB) alongside daily chemotherapy with capecitabine five days per week. Proton therapy doses range between 50.4 and 60.2 Gy relative biological effectiveness in 28 fractions. After completing this combined treatment, patients will be re-evaluated around week 21, and those meeting criteria will undergo surgery via laparotomy approximately during week 22. During the study, participants will be monitored for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) from enrollment until six months after surgery. Perioperative mortality and complications will be assessed up to 90 days post-surgery. Additional evaluations include tumor recurrence, progression-free and overall survival, pathologic tumor response, radiologic response, and quality of life assessments using specific questionnaires up to approximately five years after therapy. The study involves comprehensive medical tests, imaging, blood work, and quality of life questionnaires to track participant status and response to treatment over an extended follow-up period.
CONDITIONS
Brief Title
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed pancreatic cancer
- Diagnosis of borderline resectable cancer based on the 2017 international consensus
- No evidence of distant metastasis
- Adequate blood counts: absolute neutrophil count > 1,500 cells/mm³, platelet count > 100,000 cells/mm³
- Liver function: AST and ALT less than 2.5 times the upper limit of normal
- Total bilirubin less than 2.5 times the upper limit if recent biliary stenting, or less than 1.5 times if no stenting
- Normal serum creatinine with creatinine clearance > 30 ml/min
- Age 18 years or older
- Karnofsky performance score of 70 or higher
- No tumor invasion of stomach or duodenum
- Ability to understand diagnosis and provide informed consent
- Women of childbearing potential must use effective contraception and not breastfeed
- Signed informed consent prior to study entry
You will not qualify if you...
- Non-exocrine pancreatic tumors
- Major medical or psychiatric conditions that prevent chemotherapy, radiation, or surgery
- Presence of distant metastasis
- Pregnancy or unwillingness to use contraception
- Lactation without willingness to stop breastfeeding
- Men of childbearing potential unwilling to use contraception
- Known allergy to any study treatment components
- Previous diagnosis of more serious cancer
- Metallic prostheses or conditions preventing adequate imaging
- Local infections contraindicating radiotherapy
- Previous abdominal radiotherapy
- Prior systemic treatment for pancreatic cancer
- Hypersensitivity to paclitaxel, albumin, gemcitabine, or chemotherapy excipients
- Severe liver impairment
- Low baseline neutrophil counts (< 1.5 x 10^9/L)
- Baseline sensory or motor neuropathy grade 2 or higher
- Patient refusal to participate
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 19 weeks
Participants receive three cycles of chemotherapy with Nab-PACLitaxel and Gemcitabine over approximately 12 weeks, followed by concomitant chemotherapy with Capecitabine and proton radiotherapy over about 6 weeks.
Weekly visits for chemotherapy and daily visits during proton radiotherapy (5 days per week) with concomitant chemotherapy
Duration - 1 week
Participants undergo pre-surgical re-evaluation at week 21 and, if eligible, surgical resection of the pancreas is performed around week 22.
1 pre-surgical evaluation visit and 1 surgery visit
Duration - 6 months
Participants are monitored for perioperative mortality and complications up to 90 days after surgery, with ongoing safety and efficacy assessments up to six months after surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 2 locations
1
EBG MedAustron GmbH
Wiener Neustadt, Lower Austria, Austria, 2700
Actively Recruiting
2
Department of Surgery, LK Wiener Neustadt
Wiener Neustadt, Austria, 2700
Actively Recruiting
Research Team
P
Piero Fossati, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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