Health TrialsbyHealthPanel

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

ConditionsPancreatic CancerProton Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEBG MedAustron GmbH

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • Capecitabine

    Drug

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

  • Surgical resection of the pancreas (when feasible)

    Procedure/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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Preoperative, proton- radiotherapy combined with chemotherapyOther 5 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
from enrollment to six months after surgery
2

Perioperative Mortality and Complications

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

Time frame
90 days postoperatively

Secondary outcomes

1

Toxicity - CTCAE v5.0

CTCAE V5.0 toxicity from enrollment to six month after surgery

Time frame
from enrollment to six months after surgery
2

Tumor recurrence

local and loco-regional (i.e. in-field) tumor recurrence

Time frame
260 weeks after therapy
3

Progression free survival

loco-regional progression-free survival

Time frame
260 weeks after therapy
4

Overall survival

Overall survival

Time frame
282 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EBG MedAustron GmbH

Lead sponsor

Landesklinkum Wiener Neustadt

Collaborator

Source ClinicalTrials.gov
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