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Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced 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. Identifier: NCT03974854
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : September 22, 2020
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

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 locally advanced or metastatic PDAC.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Drug: XELOXIRI-3 Drug: Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX)
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other Names:
  • Capecitabine
  • Oxaliplatine
  • Irinotecan

Active Comparator: Arm B: Gemcitabine
1000 mg / m2 on D1, D8 and D15, every 28 days
Drug: Gemcitabine
chemotherapy with Gemcitabine regimen

Primary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria :

  • Histologically proven pancreatic ductal adenocarcinoma
  • Locally Advanced or metastatic disease
  • Measurable disease according to RECIST v1.1 criteria
  • Age ≥ 75 years;

OR age between 65 and 75 years AND with at least one frailty contraindication to the administration of chemotherapy with FOLFIRINOX:

  • Eastern Cooperative Oncology Group Performance status (ECOG-PS) 2
  • Total serum bilirubin > 1.5 ULN (biliary drainage allowed)
  • Clinico-biological frailty criteria:
  • weight loss > 10% in 6 months or > 5% in 1 month
  • or body mass index (BMI) ≤ 21
  • or serum albumin < 30 g/L
  • or ADL (Activities of Daily Living) score < 6

    • Eligible for gemcitabine as first-line chemotherapy
    • Registration in a national health care system
    • Written informed consent obtained from the patient prior to performing any protocol-related procedures

Main Exclusion Criteria:

  • Age < 65 years
  • Localized non-metastatic cancer
  • ECOG-PS 3-4
  • Previous treatment For advanced stage (locally advanced or metastatic): chemotherapy, radiochemotherapy; For localized stage: FOLFIRINOX chemotherapy (neoadjuvant or adjuvant); adjuvant chemotherapy with gemcitabine before relapse is permitted (provide it has been administered more than 6 months before)
  • Uncontrolled intercurrent cardiovascular disease
  • Known or suspected allergy or hypersensitivity to any of the study drugs (capecitabine, oxaliplatin, irinotecan, gemcitabine)
  • Bowel obstruction or sub-obstruction or impossible oral treatment
  • Prior peripheral neuropathy of grade ≥ 2
  • Known complete dihydropyrimidine dehydrogenase (DPD) or UDP-glycosyltransferase 1 polypeptide A1 (UGT1A1) deficiency
  • Inadequate hematological, hepatic, and renal functions
  • Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs (Adverse Events) or compromise the ability of the patient to give written informed consent
  • Tutelage or guardianship
  • Diagnosis of any second malignancy within the last 2 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
  • Current participation in another clinical trial using therapeutic experimental agents

Information from the National Library of Medicine

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 identifier (NCT number): NCT03974854

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Contact: Angélique Dr VIENOT +33381479999
Contact: Marion JACQUIN

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University Hospital of Besançon Recruiting
Besancon, France
Contact: Angelique VIENOT         
Principal Investigator: Angélique VIENOT         
Hôpital Nord Franche-Comté Recruiting
Montbéliard, France
Contact: Angelique VIENOT, Dr         
Principal Investigator: Christophe BORG, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Principal Investigator: Angélique VIENOT, Dr University Hospital of Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon Identifier: NCT03974854    
Other Study ID Numbers: P/2018/395
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors