Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (NCT02125136) | Clinical Trial Compass
CompletedPhase 2
Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer
Germany168 participantsStarted 2014-11
Plain-language summary
The aim ot the study is to investigate the efficacy and safety of two new intensified chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and consecutive conversion of the tumor to resectability.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Adult patients ≥ 18 years and ≤ 75 years of age
* Histologic or cytologic proven ductal adenocarcinoma of the pancreas (histologic confirmation of diagnosis is preferred)
* No distant metastases
* De novo, treatment-naïve unresectable or borderline resectable LAPC; evaluation of unresectable and borderline resectable status according to NCCN- Clinical Practice Guidelines in Oncology "pancreatic adenocarcinoma" version 1.2013. Applicable criterion/criteria have to be indicated.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Total bilirubin ≤ 2 mg/dL. Patients with a biliary stent may be included provided that bilirubin level after stent insertion decreased to ≤ 2 mg/dL and there is no cholangitis.
* Adequate renal, hepatic and bone marrow function, defined as
* Serum creatinine ≤ 1.25 x Upper limit of normal (ULN)
* Calculated creatinine clearance ≥ 60 mL/min according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
* Aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase)GOT and/or Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (GPT) ≤ 2.5 x ULN
* Partial thromboplastin time (PTT) ≤ 1.5 x ULN and Quick value ≥ 70%
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Haemoglobin ≥ 8g/dL
* Platelets ≥ 100 x 109/L
* Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment and must agree to use ef…