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

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 14, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Pancreatic CancerProton Therapy
Interventions
RADIATION

Proton 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.

DRUG

Nab-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."

DRUG

Gemcitabine

"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."

DRUG

Capecitabine

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

PROCEDURE

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.

Trial Locations (2)

2700

RECRUITING

EBG MedAustron GmbH, Wiener Neustadt

RECRUITING

Department of Surgery, LK Wiener Neustadt, Wiener Neustadt

All Listed Sponsors
collaborator

Landesklinkum Wiener Neustadt

OTHER

lead

EBG MedAustron GmbH

INDUSTRY