Resectable pancreatic cancer MedDRA version: 21.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ONIVYDE
Pharmaceutical Form: Solution for infusion
Trade Name: OXALIPLATINO ACCORD - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 40 ML
Product Name: oxalipla
Sponsors
CENTRO RICERCHE CLINICHE DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to understand and provide written informed consent. 2. = 18 years of age. 3. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas. 4. Adequate hepatic, renal and hematological function. 5. Patients must have measurable disease in the pancreas, with no evidence of metastatic disease on imaging of the chest, abdomen and pelvis (contrast-enhanced CT or MRI abdomen with contrast instead of abdominal CT); PET scans alone will not be adequate alternatives. 6. The primary tumor must be surgically resectable, defined as: a. no involvement (abutment or encasement) of the major arteries (celiac, common hepatic and/or superior mesenteric artery); b. no involvement or =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Serum total bilirubin =2 x ULN (biliary drainage is allowed for biliary obstruction). 2. Severe renal impairment (CLcr = 30 ml/min). 3. Inadequate bone marrow reserves as evidenced by: 4. ANC = 1,500 cells/µl; or Platelet count = 100,000 cells/µl; or Hemoglobin = 9 g/dL 5. KPS grade 2. 9. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months. 10. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings. 11. Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician’s opinion might compromise the patient’s health. 12. Known hypersensitivity to any of the components of nanoliposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin. 13. Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors 14. Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study ¿ 15. Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results ¿ 16. Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of nanoliposomal irinotecan (nal-IRI). Females of Childbearing Potential must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index < 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 3 months after last application of program treatment. A female subject is considered to be of childbearing potential unless she is age = 50 years and naturally amenorrhoeic for = 2 years, or unless she is surgically sterile. Males must agree not to father a child (including not donating sperm) during the course of the trial and for at least 6 months after last administration of study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to determine the proportion of patients with resectable pancreatic cancer achieving macroscopically complete tumor removal with negative microscopic surgical margins (R0) resection after preoperative nanoliposomal irinotecan (nal-IRI), Oxaliplatin, Leucovorin (LV), 5-FluoroUracil (5-FU);Secondary Objective: To determine 2-year OS in patients treated with multimodality approach combining perioperative chemotherapy with surgery. To determine DFS from the time of resection in patients treated with multimodality approach combining perioperative chemotherapy with surgery. To estimate frequency and severity of adverse events associated with chemotherapy. To determine ORR following preoperative chemotherapy. To estimate proportion of patients going to surgery for resection after preoperative chemotherapy. To estimate pCR after R0 or macroscopically complete tumor removal with any positive microscopic surgical margin (R1) resection. To assess lymph node status. To correlate pre-operative response of CA19-9 with DFS and OS. To assess surgical mortality and morbidity.;Primary end point(s): Number of patients achieving R0 resection, defined accordingly to the International Study Group of Pancreatic Surgery guidelines as a resection margin >1 mm. Tumour clearance should be given for all of the following margins: anterior, posterior, medial, or superior mesenteric groove, SMA, pancreatic transection, bile duct, and enteric. Surgery will be performed after receiving 3 cycles of chemotherapy preoperatively planned at up to 12 weeks. It will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS from enrollment to death from any cause. ; DFS from randomization to recurrence (loco-regional or distant) or death due to any cause.; Incidence of toxicities greater than grade 4, using Common Terminology Criteria for Adverse Events version 4.0.; ORR after neoadjuvant chemotherapy with RECIST 1.1.; Overall resection rate.; Number of partecipants achieving pCR.; Lymph node status; Biochemical response rate by Ca 19.9 decrease; Number of partecipants experiencing perioperative mortality or morbidity;Timepoint(s) of evaluation of this end point: time frame up to 2 years; time frame up to 2 years.; time frame every two weeks during treatment; time frame up to 2 year; time frame immediately after surgery; time frame up to 2 years; time frame immediately after surgery; time frame after 3 months of induction therapy; time frame up to 30 days from surgery | — |
Countries
Italy
Contacts
Public ContactCentro Ricerche Cliniche di Verona
Centro Ricerche Cliniche di Verona
Outcome results
None listed