Resectable pancreatic cancer and risk factors MedDRA version: 21.0 Level: LLT Classification code 10033608 Term: Pancreatic cancer resectable System Organ Class: 100000004864
Conditions
Interventions
Product Name: Irinotecan
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Concentration unit: mg/m2 milligram(s)/square meter
Sponsors
Fundación para la Gestión de la Investigación Biomédica de Cádiz-INIBICA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors 2. Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA) performed by Echoendoscopy. 3. Patients who have not received prior therapy for pancreatic cancer. 4. Biliary drainage prior to neoadjuvant treatment. 5. Age> 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 116
Exclusion criteria
Exclusion criteria: 1. Patients with resectable pancreatic adenocarcinoma without risk factors. 2. Patients with borderline pancreatic adenocarcinoma. 3. Patients with locally advanced pancreatic adenocarcinoma. 4. Patients with metastatic adenocarcinoma of the pancreas. 5. Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma 6. Pathological subtypes other than adenocarcinoma. 7. Patients included in a clinical trial in a period of 6 months prior to inclusion in this study. 8. A past history of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition. 9. Uncontrolled breakthrough disease. 10. Patients with HIV, HBV and HCV positive and currently under antiretroviral therapy. 11. Other active malignancies 12. Pre-existing neuropathy, grade > 1. 13. Inflammatory bowel disease that is not controlled, or under current active therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess overall survival in patients treated with neoadyuvant chemotherapy before surgery-resection and adyuvant chemotherapy vs patients traeted only with adjuvant chemotherapy after surgery-resection;Secondary Objective: To assess in both patients (experimental vs control arms): - Progression free survival - Number of completed cycles fo chemotherapy - Local and metastatic recurrence - Post-surgical morbidity - Resection rate R0 - Safety of the neoadyuvant chemotherapy;Primary end point(s): Period (weeks) until death;Timepoint(s) of evaluation of this end point: Not applicable, since time is the endpoint of evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Period (weeks) until recurrence disease (local or metastatic recurrence) - Number of completed chemotherapy cycles - development and location of new lesions - Number and data about post-surgical events (if any) - Resection rate RO - Number and data about adverse events.;Timepoint(s) of evaluation of this end point: These data will be recordered along the follow up period of patients (since cycle 1- day 1 until the end of the follow up period) | — |
Countries
Spain
Contacts
Public ContactLaura Quintana López
Fundación para la Gestión de la Investigación Biomédica de Cádiz-INIBICA
Outcome results
None listed