METASTATIC ADENOCARCINOMA OF PANCREATIC MedDRA version: 21.0 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Institut régional du Cancer de Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 on the date the consent is signed. 2. Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data. 3. One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast). 4. Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay = 6 months between the last treatment and the recurrence is respected. 5. WHO performance status = 1. 6. Uracilemia =65 years) yes F.1.3.1 Number of subjects for this age range 210
Exclusion criteria
Exclusion criteria: . Known brain metastasis. 2. Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease. 3. Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment. 4. Known Gilbert's syndrome or homozygous for validated UGT1A1 * 28 5. Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder tumor (Ta, Tis, and T1) or a tumor with a good prognosis treated curatively without chemotherapy and without any sign of disease in the 3 years preceding inclusion. 6. Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months. 7. Peripheral sensory neuropathy = grade 2 at the time of inclusion. 8. ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women 9. History of chronic inflammatory disease of the colon or rectum 10. Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders) 11. Intolerance or allergy to one of the study drugs (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to an excipient of one of the drugs (example: fructose) described in the sections Against SPC indications or Special Warnings and Precautions or Prescribing Information 12. Legal incapacity (patient under curatorship or under tutorship) 13. Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (ß-hCG serum) documented 72 hours before inclusion 14. Patients using AVK (Coumadin ...) (possible modification of treatment before inclusion) 15. Active and uncontrolled bacterial or viral or fungal infection requiring systemic treatment. 16. History or known HIV infection. 17. History of peripheral arterial disease (eg, claudication, Leo Buerger's disease). 18. Patient who received a live attenuated vaccine within 10 days before inclusion 19. Patients with a history of pulmonary fibrosis or interstitial pneumonia. 20. The patient refuses or is unable to comply with study procedures. 21. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons. 22. Participation in another clinical study with an investigational product within the last 30 days prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression-free survival between the experimental treatment GABRINOX and the standard treatment FOLFIRINOX in patients with first-line metastatic pancreatic adenocarcinoma;Secondary Objective: - Evaluate the tolerance of the treatments - Evaluate the objective response rate - Evaluate the disease control rate - Evaluate overall survival - Evaluate the quality of life ;Primary end point(s): Progression-free survival defined as the time between randomization and the onset of the first documented progression or death from any cause to the RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: At the first documented progression or the date of death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of adverse events assessed according to the NCI-CTC AE classification in force - Objective response rate (best response during treatment) defined as the percentage of complete or partial response. The tumor response is evaluated according to the RECIST 1.1 criteria - Disease control rate defined as the percentage of complete or partial response or stability - Overall survival defined as the time between randomization and the onset of death regardless of the cause. - Quality of life assessed by the EORTC QLQ-C30 and QLQ-PAN26 questionnaires at inclusion, then every 2 months until 12 months then at 16 months, 20 months and 24 months.;Timepoint(s) of evaluation of this end point: - At the Best response - At the death - Every 2 month | — |
Countries
France
Contacts
Public ContactDr Jean-Pierre BLEUSE
Institut régional du cancer de Montpellier
Outcome results
None listed