Pancreatic CancerPARCNCT04894643
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
A study testing Proton Ions, Nab-PACLitaxel and Gemcitabine in people with Pancreatic Cancer and Proton Therapy, run by EBG MedAustron GmbH at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Proton Therapy
- What is being tested?
- Proton Ions, Nab-PACLitaxel and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustria
- Study dates
- 14 Sep 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Recruiting
EBG MedAustron GmbH
Wiener Neustadt, Lower Austria, 2700
Piero Fossati, M.D., +43 2622 26 100 ext. 408, piero.fossati@medaustron.at
Piero Fossati, M.D.
- Recruiting
Department of Surgery, LK Wiener Neustadt
Wiener Neustadt, 2700
Friedrich Längle, Prim., Univ. Doz., M.D., +43 2622 9004 ext. 2484, friedrich.laengle@wienerneustadt.lknoe.at
Friedrich Längle, Prim., Univ. Doz., M.D.
About this study
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.
Read the 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 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.
- Conditions
- Pancreatic Cancer, Proton Therapy
- Being tested
- Proton Ions, Nab-PACLitaxel, Gemcitabine, Capecitabine, Surgical resection of the pancreas (when feasible)
- Keywords
- Proton therapy combined with chemotherapy, Borderline Resectable Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton IonsRadiation
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.
Nab-PACLitaxelDrug
Also called Abraxane®
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.
GemcitabineDrug
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.
CapecitabineDrug
Concomitant to proton-radiotherapy (on the same days, within week 14-19)
Surgical resection of the pancreas (when feasible)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Proton Ions; Drug: Nab-PACLitaxel; Drug: Gemcitabine; Drug: Capecitabine; Procedure: Surgical resection of the pancreas (when feasible) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 90 days postoperatively
Secondary outcomes (9)
Toxicity - CTCAE v5.0
CTCAE V5.0 toxicity from enrollment to six month after surgery
Measured: from enrollment to six months after surgery
Tumor recurrence
local and loco-regional (i.e. in-field) tumor recurrence
Measured: 260 weeks after therapy
Progression free survival
loco-regional progression-free survival
Measured: 260 weeks after therapy
Overall survival
Overall survival
Measured: 282 weeks
Pathologic tumor response
Assessment of pathologic tumor response to pre-operative combined proton- chemotherapy (R0 margin and N0, degree of tumor cell necrosis in the resected tumor specimen)
Measured: 260 weeks
Radiologic response
Assessment of radiologic response of pre-operative chemoradiotherapy. Response to preoperative treatment will be scored with the Japan Pancreas Society (JPS) classification which is a synthesis from the Evans and College of American Pathologists classification (Grade 1: poor or no response to Grade 4: complete response)
Measured: 263 weeks after proton therapy
Quality of Life questionnaire: Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep)
Patient reported Quality of Life (for assessing disease-related symptoms and health-related quality of life). The higher the score the better the Quality of Life.
Measured: 282 weeks
Quality of Life questionnaire: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30)
Questionnaire developed to assess the quality of life of cancer patients. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 282 weeks
Quality of Life questionnaire: Brief Pain Inventory
The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain.The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely.
Measured: 282 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start14 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EBG MedAustron GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landesklinkum Wiener Neustadt
- Responsible party
- Sponsor
- Investigators
- Piero Fossati, M.D., Principal investigator, EBG MedAustron GmbHFriedrich Längle, Prim., Univ. Doz., M.D., Principal investigator, LK Wiener Neustadt, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894643
- Sponsor's protocol ID
- PARC-MA-062019
- Acronym
- PARC
- Status last verified
- Mar 2026
- First submitted
- 10 May 2021
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04894643
- Acronym / sponsor ID
- PARC / PARC-MA-062019
- Conditions
- Pancreatic Cancer, Proton Therapy
- Keywords
- Proton therapy combined with chemotherapy, Borderline Resectable Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- EBG MedAustron GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Landesklinkum Wiener Neustadt
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Preoperative, proton- radiotherapy combined with chemotherapy | Other | Radiation: Proton Ions, Drug: Nab-PACLitaxel, Drug: Gemcitabine, Drug: Capecitabine, Procedure: Surgical resection of the pancreas (when feasible)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton IonsAccording 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. | Radiation | Preoperative, proton- radiotherapy combined with chemotherapy |
| Nab-PACLitaxelAlso: Abraxane®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. | Drug | Preoperative, proton- radiotherapy combined with chemotherapy |
| GemcitabineChemotherapy 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. | Drug | Preoperative, proton- radiotherapy combined with chemotherapy |
| CapecitabineConcomitant to proton-radiotherapy (on the same days, within week 14-19) | Drug | Preoperative, proton- radiotherapy combined with chemotherapy |
| Surgical resection of the pancreas (when feasible)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. | Procedure or surgery | Preoperative, proton- radiotherapy combined with chemotherapy |
Primary outcome
Toxicity - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: from enrollment to six months after surgery
Incidence of CTCAE version 5.0 Grade 4 non hematological toxicity from enrollment to six months after surgery
Perioperative Mortality and Complications
Time frame: 90 days postoperatively
Incidence of 90-days-perioperative mortality and incidence of Clavien Dindo Grade III complication rate during hospitalization
9 secondary outcomes
Toxicity - CTCAE v5.0
Time frame: from enrollment to six months after surgery
Tumor recurrence
Time frame: 260 weeks after therapy
Progression free survival
Time frame: 260 weeks after therapy
Overall survival
Time frame: 282 weeks
Pathologic tumor response
Time frame: 260 weeks
Radiologic response
Time frame: 263 weeks after proton therapy
Quality of Life questionnaire: Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep)
Time frame: 282 weeks
Quality of Life questionnaire: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30)
Time frame: 282 weeks
Quality of Life questionnaire: Brief Pain Inventory
Time frame: 282 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piero Fossati, M.D. principal investigator
EBG MedAustron GmbH
Friedrich Längle, Prim., Univ. Doz., M.D. principal investigator
LK Wiener Neustadt, Department of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Ions, Nab-PACLitaxel and Gemcitabine in people with Pancreatic Cancer and Proton Therapy, run by EBG MedAustron GmbH at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piero Fossati, M.D. (+43 664 80878 ext. 408, piero.fossati@medaustron.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: from enrollment to six months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.