Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX)

  • STATUS
    Recruiting
  • End date
    Jul 25, 2024
  • participants needed
    90
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 25 May 2022
measurable disease
fluorouracil
metastasis
oxaliplatin
metastatic adenocarcinoma
gemcitabine
leucovorin
irinotecan
serum total bilirubin
pdac
folfirinox
ductal adenocarcinoma
pancreatic ductal adenocarcinoma

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.

Details
Condition Metastatic Pancreatic Adenocarcinoma
Treatment Gemcitabine, XELOXIRI-3
Clinical Study IdentifierNCT03974854
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Age < 65 years
Localized non-metastatic cancer
ECOG-PS 3-4
Uncontrolled intercurrent cardiovascular disease
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
Bowel obstruction or sub-obstruction or impossible oral treatment
it has been administered more than 6 months before)
Known or suspected allergy or hypersensitivity to any of the study drugs
Inadequate hematological, hepatic, and renal functions
(capecitabine, oxaliplatin, irinotecan, gemcitabine)
Tutelage or guardianship
Prior peripheral neuropathy of grade ≥ 2
Current participation in another clinical trial using therapeutic experimental agents
Known complete dihydropyrimidine dehydrogenase (DPD) or UDP-glycosyltransferase 1
polypeptide A1 (UGT1A1) deficiency
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
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
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