Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Metastatic Pancreatic Adenocarcinoma (ALIX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03974854|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Current standard of care for patients with metastatic Pancreatic Ductal AdenoCarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Due to more hematologic (neutropenia) and gastrointestinal toxicities, FOLFIRINOX is only administered in fit patients (age < 75 years, ECOG Performance status 0-1, and bilirubin < 1.5 ULN).
However, elderly or frail patients represent more than half of patients with PDAC and are treated with gemcitabine monochemotherapy. Maintaining more than one drug (polychemotherapy) may improve survival and quality of life in this population.
ALIX is a non-comparative randomized 2:1 phase II study. This study will assess the efficacy and safety of the polychemotherapy with XELOXIRI-3 versus gemcitabine as first-line chemotherapy in elderly or frail patients with metastatic PDAC.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma||Drug: XELOXIRI-3 Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Metastatic Pancreatic Adenocarcinoma (ALIX)|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||July 2022|
Experimental: Arm A: XELOXIRI-3
capecitabine 625 mg/m2 twice daily on days 1-7 oxaliplatine 85 mg/m2 on Day 1 irinotecan 90 mg/m2 on Day 3, every 14 days
chemotherapy with XELOXIRI-3 regimen
Active Comparator: Arm B: Gemcitabine
1000 mg / m2 on D1, D8 and D15, every 28 days
chemotherapy wth Gemcitabine regimen
- 6 months Progression-Free Survival (PFS) rate [ Time Frame: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974854
|Contact: Angélique Dr VIENOTemail@example.com|
|Contact: Marion JACQUINfirstname.lastname@example.org|
|Principal Investigator:||Angélique VIENOT, Dr||University Hospital of Besançon|