RANDOMIZED PHASE II MULTICENTRIC TRIAL EVALUATING THE EFFECTIVENESS OF A SEQUENTIAL GEMCITABINE PLUS NABPACLITAXEL (GEMBRAX) TREATMENT FOLLOWED BY FOLFIRINOX VERSUS FOLFIRINOX IN PATIENTS TREATED FOR FIRST LINE METASTATIC PANCREATIC CANCER - GABRINOX 2

Overview

No summary available.

Registry

who.int

Start Date

June 24, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 \<16 ng / ml
•7\. Acceptable hematological assessment at inclusion (obtained within 14 days before the start of treatment) defined by:
•Neutrophils \= 2 × 109 / L;
•Platelets \= 100,000 / mm3 (100 × 109 / L);
•Hemoglobin \= 9 g / dl.

•. 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)