Potentially resectable pancreatic cancer MedDRA version: 16.1 Level: LLT Classification code 10033608 Term: Pancreatic cancer resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Gemcitabine
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg/m2 milligram(s)/square meter
Concentration
Sponsors
FUNDACION HOSPITAL DE MADRID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Patients with cytological or anathomopathological diagnosis of pancreatic carcinoma 2- The pancreatic tumor is resectable or borderline 3- Older than 18 years 4- ECOG performance status 0-1 5- Adequate hematologic function: a. Neutrophils > 1.500 b. Hemoglobin > 9 c. Platelets > 100.000 6- Adequate liver and kidney function: a. Bilirubin = 40ml/min 7- Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1.- Patients unable to complete the study procedures for geographical, psychiatric or social reasons. 2.- Patients with some physical or psychical condition which contraindicates the study treatment 3.- Patients with active infection or another significant or autoimmune disease. 4.- ECOG performance status >= 2. 5.- Chronic hepatic disease (cirrhosis, chronic hepatitis) 6.- Another solid or hematologic concurrent tumor or previous tumors for the last 5 years. (except for basal cell carcinoma and skin epidermoid no relapsed tumors) 7.- Pregnancy or breastfeeding period. Women of child-bearing potential and men have to use contraceptive methods or be surgically sterilized. 8.- Patients who are taking oral anticoagulants and it cannot be replaced for subcutaneous low molecular weight heparin. 9.- Distant pancreatic cancer metastasis. 10.- Patients who have been previously treated for pancreatic carcinoma with radiotherapy, chemotherapy or surgical treatment different from biliary derivation or biopsy. 11.- Impossibility or contraindication to complete any study procedure (Eco-endoscopy, NMR, MisoPET) 12.- Prior history of neuropathy or polyneuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the variation of the elastographic index between patients treated with Gemcitabine plus nab-paclitaxel and patients treated with FOLFIRINOX;Secondary Objective: - To compare Cancer Associated Fibroblasts (CAF) density in the tumor samples between both arms - To assess tumor response by RECIST criteria in both arms - To determine the surgery rates in both arms and rates of R0 resections (R0 is defined as complete resection with no tumor within 1 mm of resection margins) in both arms. - Histological response (according to Ryan criteria) in both arms. - Progression-free survival in both arms. - Overall survival in both treatment groups - To measure tumor vascularization changes by MisoPet before and after treatment with FOLFIRINOX and with Gemcitabine plus nab-paclitaxel, and their correlation with vascularization of the surgical sample in both arms. - Determine CA19.9 decrease in patients treated with FOLFIRINOX and patients treated with Gemcitabine plus nab-paclitaxel at the end of the neoadyuvant treatment. - Assessment of CA19.9 early decrease in both arms;Primary end point(s): The means of the difference in elastographic values before and after treatment in both arms will be compared;Timepoint(s) of evaluation of this end point: Before and after both arms treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - PET-TAC.- 18FDG-PET will be used for measure SUV max (Standard Uptake Value max) for pancreatic lesion. EORTC criteria will be following in order to assess PET response. - CA19.9 response - Thorax-abdomen-pelvis TAC with iv contrast. RECIST 1.1 criteria will be followed. For response evaluation: ((Post-basal value ? basal value)/basal value) x 100. The following definitions will be used for assess the response. Complete response (CR) if the target lesion disappears; Partial response (PT) if the target lesion decreases at least 30%; Disease progression (DP) if the target lesion increases 20% or more. Stable disease (SD) if the lesion cannot be included in DP or PT categories. If the target lesion cannot be measure correctly it will be no gradable (NG). - MISO-PET to assess the tumor vascularization. - Assessment of tumor sample: 1.- Resection margins which could be R0, R1 or R2. 2.- Regression degree of the histological response by the following scale: (0) No tumor; (1) tumor cells, isolated tumor nests; (2) frequent tumor nests; (3) minimal response; (4) no response.;Timepoint(s) of evaluation of this end point: PET-TAC, CA19.9 response, MISO-PET, Thorax-abdomen-pelvis TAC - Before and after treatment Assessment of tumor simple - After treatment | — |
Countries
Spain
Contacts
Public ContactDr. Rafael álvarez
Fundación Hospital de Madrid
Outcome results
None listed