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

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

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.

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

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 resectable pancreatic cancer. Aim of this study is to test referral and enrollment procedures as well as technical feasibility. Proton therapy will be delivered in MedAustron, which is a stand alone facility. Pancreatic cancer patients are typically complex cases that require multidisciplinary care. Moreover delivery of high dose of proton therapy to large volumes including the upper abdomen lymphnodes and pancreatic neural plexus is technically challenging, therefore a feasibility study is deemed necessary. Following this study, a larger study will be performed aiming to confirm the ability of preoperative chemotherapy + concomitant chemo-proton therapy to improve resectability and ultimately outcome of borderline resectable pancreatic cancer without increase in toxicity.

Connect with a study center

  • EBG MedAustron GmbH

    Wiener Neustadt, Niederösterreich 2700
    Austria

    Active - Recruiting

  • Department of Surgery, LK Wiener Neustadt

    Wiener Neustadt, 2700
    Austria

    Active - Recruiting

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