10
Participants
Start Date
September 14, 2020
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2027
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.
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."
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."
Capecitabine
Concomitant to proton-radiotherapy (on the same days, within week 14-19)
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.
RECRUITING
EBG MedAustron GmbH, Wiener Neustadt
RECRUITING
Department of Surgery, LK Wiener Neustadt, Wiener Neustadt
Landesklinkum Wiener Neustadt
OTHER
EBG MedAustron GmbH
INDUSTRY