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

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    EBG MedAustron GmbH
Updated on 7 October 2022
platelet count
neutrophil count
cancer chemotherapy
resectable pancreatic cancer


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.


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.

Condition Pancreatic Cancer, Proton Therapy
Treatment Capecitabine, Gemcitabine, Nab-paclitaxel, Proton Ions, Surgical resection of the pancreas (when feasible)
Clinical Study IdentifierNCT04894643
SponsorEBG MedAustron GmbH
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

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 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 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note