Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer

NCT04894643 | Recruiting

• 1 other identifier: PARC-MA-062019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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 (when feasible) for patients with borderline resectable pancreatic cancer.

Conditions

Pancreatic Cancer; Proton Therapy

Keywords

Proton therapy combined with chemotherapy; Borderline Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Toxicity - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  Incidence of CTCAE version 5.0 Grade 4 non hematological toxicity from enrollment to six months after surgery

  from enrollment to six months after surgery

• Perioperative Mortality and Complications

  Incidence of 90-days-perioperative mortality and incidence of Clavien Dindo Grade III complication rate during hospitalization

  90 days postoperatively

Secondary Outcomes (9)

• Toxicity - CTCAE v5.0

  from enrollment to six months after surgery

• Tumor recurrence

  260 weeks after therapy

• Progression free survival

  260 weeks after therapy

• Overall survival

  282 weeks

• Pathologic tumor response

  260 weeks

Study Arms (1)

Preoperative, proton- radiotherapy combined with chemotherapy

OTHER

Patients treated with three cycles of chemotherapy with Nab-PACLitaxel (Abraxane®) (125 mg/m² on day 1, 8, 15; powder for making a infusion solution) and Gemcitabine (1000 mg/m² on day 1, 8, 15; powder for making a infusion solution), followed by concomitant chemotherapy with capecitabine (1.660ml/m² on 5 days per week during the radiation therapy) and proton-therapy (with simultaneous integrated boost (SIB) 50.4 Gy Relative Biological Effectiveness (RBE) and 60.2 Gy (RBE) in 28 fractions of 1.8 Gy (RBE) and 2.15 Gy (RBE) 5 days per week), followed by re-evaluation and surgery

Radiation: Proton Ions; Drug: Nab-PACLitaxel; Drug: Gemcitabine; Drug: Capecitabine; Procedure: Surgical resection of the pancreas (when feasible)

Interventions

Proton Ions RADIATION

According to the radiation plan (between 50.4 and a maximum of 60.2 Gy) after Chemotherapy with Nab-PACLitaxel (Abraxane®) + Gemcitabine and concomitant to Capecitabine.

Preoperative, proton- radiotherapy combined with chemotherapy

Nab-PACLitaxel DRUG

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy. It will be administered as intra venous infusion over 30 minutes.

Also known as: Abraxane®

Preoperative, proton- radiotherapy combined with chemotherapy

Gemcitabine DRUG

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy. Gemcitabine will also be administered as intra venous infusion over 30 minutes immediately after Nab-PACLitaxel.

Preoperative, proton- radiotherapy combined with chemotherapy

Capecitabine DRUG

Concomitant to proton-radiotherapy (on the same days, within week 14-19)

Preoperative, proton- radiotherapy combined with chemotherapy

Surgical resection of the pancreas (when feasible) PROCEDURE

Pre surgical re-evaluation will be performed at week 21 after enrollment. Patients fulfilling surgery-entry criteria, which consist of no distant metastasis, no massive ascites, no massive pleural effusion, no serious infection, no serious, unresolved chemoradiotherapy related, adverse events and adequate organ system function, will undergo surgery on week 22 (± 1 week). This should be performed via laparotomy.

Preoperative, proton- radiotherapy combined with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 (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

You may not qualify 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
• 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

Sponsors & Collaborators

• EBG MedAustron GmbH: lead
• Landesklinkum Wiener Neustadt: collaborator

Study Sites (2)

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, 2700, Austria

RECRUITING

Department of Surgery, LK Wiener Neustadt

Wiener Neustadt, 2700, Austria

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Protons; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Piero Fossati, M.D.

  EBG MedAustron GmbH

  PRINCIPAL INVESTIGATOR

• Friedrich Längle, Prim., Univ. Doz., M.D.

  LK Wiener Neustadt, Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piero Fossati, M.D.

CONTACT

+43 664 80878; piero.fossati@medaustron.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 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

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 20, 2021
• Study Start: September 14, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

AU (2)