Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of the present study is to test if in situations of borderline resectable patients a neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase the median OS rates above 30 months that means at least 12 months more than the 18-20 months generally described.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Francois Baclesse, Luxembourg

Criteria

Inclusion Criteria:

• Biopsy proven pancreatic adenocarcinoma

• Borderline resectable pancreatic adenocarcinoma (NCCN guidelines)

• OMS status ≤2

• Age at presentation >18 y

• Absolute neutrophil counts >1500/ml

• Absolute platelet count >100000/ml

• GOT and GPT <2.5 x the upper limit of normal

• Total bilirubin < the upper limit of normal

• Serum creatinin < upper limit of normal

• Coagulation test within limit of normal (Prothrombin time, INR) +/- 15%

• No evidence of jaundice at enrolment. If stent required to alleviate jaundice it should be metallic

• Patient must be able to eat without a feeding tube and can take medications orally

• Disease must be encompassed in a reasonable radiation field

• Signed informed consent

Exclusion Criteria:

• Distant metastases

• Evolutive disease after the neoadjuvant chemotherapy course according RECIST criteria

• Neuroendocrine tumors

• Peritoneal dissemination visualized at diagnostic abdominal CT scan

• Pathologic abdominal nodes visualized at diagnostic abdominal CT scan outside the pancreatic area

• Pathologic PET scan outside the pancreatic area

• Inoperability for medical reasons

• Inability to tolerate chemotherapy for medical (in particular grade II or more neuropathy) or allergic purposes, or for OMS score >2

• Inability to tolerate Whipple resection

• Collagenose diseases

• Cancer evolution outside the pancreatic bed at the PET scanner performed just after the 3 neo adjuvant chemotherapy cycles

• Any previous cancer in the 5 years excepted a basal skin cell carcinoma or in situ cervical cancer

• Active infection with HIV, Hepatitis B or c

• Pregnant patient