Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma
NCT ID: NCT03974854
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2019-07-08
2024-02-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
XELOXIRI-3
chemotherapy with XELOXIRI-3 regimen
Arm B: Gemcitabine
1000 mg / m2 on D1, D8 and D15, every 28 days
Gemcitabine
chemotherapy with Gemcitabine regimen
Interventions
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XELOXIRI-3
chemotherapy with XELOXIRI-3 regimen
Gemcitabine
chemotherapy with Gemcitabine regimen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Angélique VIENOT, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Besançon
Locations
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University Hospital of Besançon
Besançon, , France
Hôpital Nord Franche-Comté
Montbéliard, , France
CH Mulhouse
Mulhouse, , France
CHU Nancy
Nancy, , France
CHU Reims
Reims, , France
Countries
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Other Identifiers
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P/2018/395
Identifier Type: -
Identifier Source: org_study_id