RecruitingNot ApplicableNCT04894643

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

Sponsor

EBG MedAustron GmbH

Enrollment

10 participants

Start Date

Sep 14, 2020

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Proton Therapy

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

Min Age: 18 Years

Inclusion Criteria10

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 Criteria17

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

Interventions

RADIATIONProton Ions

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.

DRUGNab-PACLitaxel

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.

DRUGGemcitabine

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.

DRUGCapecitabine

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

PROCEDURESurgical 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.