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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 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 absol…
Inclusion Criteria:
* 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 Criteria:
* 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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.