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Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy (FOLFIRINOX3 P)

Primary Purpose

Metastatic Pancreatic Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
FOLFIRINOX treatment
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring FOLFIRINOX treatment, pancreatic cancer, first line chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female age > 18 years at time of study entry Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Patients with pancreatic adenocarcinoma Patients with unresectable locally advanced pancreatic cancer or metastatic pancreatic cancer Patients with no history of chemotherapy (prior adjuvant or neoadjuvant chemotherapy accepted if the time between the end of chemotherapy and recurrence is greater than 12 months) and no history of curative radiotherapy for metastatic or locally advanced disease. Palliative radiotherapy is accepted. Patient eligible for treatment with FOLFIRINOX (5-FU, Irinotecan, Oxaliplatin and folinic acid) including but not limited to: No active heart disease An ECG with a QT/QTc interval ˂ to 450 ms for men and ˂ to 470 ms for women. No uncontrolled hypertension defined by systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management. A negative pregnancy test if applicable Tumor evaluation (CT scan) performed within 4 weeks (28 days) prior to inclusion with at least one measurable lesion according to RECIST 1.1 criteria Patient fit and able to comply with the protocol for the duration of the study, including treatment, visits, scheduled examinations and follow-up. Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days) Information given and informed consent signed Patient affiliated to a social security scheme Men and women must have an effective contraceptive method. Exclusion Criteria: Patient with neuroendocrine carcinoma or acinar cell carcinoma Other cancer in the 5 years preceding inclusion or concomitant (except cancer in situ of the uterine cervix or cutaneous basal cell carcinoma). Presence of brain metastasis(es) Estimated prognosis < 3 months History of grade 4 toxicity to oxaliplatin, irinotecan or 5FU if history of adjuvant/neoadjuvant chemotherapy Sequellar toxicity > grade 1 if previous adjuvant/neoadjuvant chemotherapy Hypersensitivity to any component of FOLFIRINOX® treatment. Current participation or participation within 30 days prior to inclusion in another therapeutic trial with an investigational compound and/or completion of radiotherapy within 10 days prior to the start of treatment Evidence of a homozygous or heterozygous DPYD mutation and/or uracilemia >16ng/mL and/or homozygous UGT1A1 genotype. Pregnancy, breastfeeding Inability to sign informed consent or to undergo medical monitoring of the trial for geographical, social or psychological reasons including, but not limited to, psychiatric illness compromising comprehension of information or conduct of the study. Patient under guardianship, curatorship or safeguard of justice.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FOLFIRINOX treatment

    Arm Description

    Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.

    Outcomes

    Primary Outcome Measures

    Progression-free survival (PFS)
    Progression-free survival (PFS) on FOLFIRINOX3 at 6 months.

    Secondary Outcome Measures

    Overall survival (OS)
    Overall survival (OS) is defined as the time interval between the date of inclusion and the date of death from any cause.
    Acute and late toxicities (adverses events)
    Acute toxicity is defined as toxicity occurring within 6 months of the start of chemotherapy. A toxicity is late if it occurs more than 6 months after the start of chemotherapy.
    Quality of life (QoL)
    Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the cancer-specific QLQ-C30
    Quality of life (QoL)
    Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the QLQPAN26,a module specific to pancreatic cancer.

    Full Information

    First Posted
    July 20, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Centre Georges Francois Leclerc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05988814
    Brief Title
    Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy
    Acronym
    FOLFIRINOX3 P
    Official Title
    Phase II Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy (FOLFIRINOX3 Pancréas)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2028 (Anticipated)
    Study Completion Date
    November 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Georges Francois Leclerc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.
    Detailed Description
    Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer. Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Pancreatic Cancer
    Keywords
    FOLFIRINOX treatment, pancreatic cancer, first line chemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FOLFIRINOX treatment
    Arm Type
    Experimental
    Arm Description
    Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.
    Intervention Type
    Drug
    Intervention Name(s)
    FOLFIRINOX treatment
    Intervention Description
    Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression
    Primary Outcome Measure Information:
    Title
    Progression-free survival (PFS)
    Description
    Progression-free survival (PFS) on FOLFIRINOX3 at 6 months.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Overall survival (OS)
    Description
    Overall survival (OS) is defined as the time interval between the date of inclusion and the date of death from any cause.
    Time Frame
    24 months
    Title
    Acute and late toxicities (adverses events)
    Description
    Acute toxicity is defined as toxicity occurring within 6 months of the start of chemotherapy. A toxicity is late if it occurs more than 6 months after the start of chemotherapy.
    Time Frame
    Until 30 days after the end of treatment
    Title
    Quality of life (QoL)
    Description
    Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the cancer-specific QLQ-C30
    Time Frame
    Until the end of treatment an average of 14 months
    Title
    Quality of life (QoL)
    Description
    Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the QLQPAN26,a module specific to pancreatic cancer.
    Time Frame
    Until the end of treatment an average of 14 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female age > 18 years at time of study entry Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Patients with pancreatic adenocarcinoma Patients with unresectable locally advanced pancreatic cancer or metastatic pancreatic cancer Patients with no history of chemotherapy (prior adjuvant or neoadjuvant chemotherapy accepted if the time between the end of chemotherapy and recurrence is greater than 12 months) and no history of curative radiotherapy for metastatic or locally advanced disease. Palliative radiotherapy is accepted. Patient eligible for treatment with FOLFIRINOX (5-FU, Irinotecan, Oxaliplatin and folinic acid) including but not limited to: No active heart disease An ECG with a QT/QTc interval ˂ to 450 ms for men and ˂ to 470 ms for women. No uncontrolled hypertension defined by systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management. A negative pregnancy test if applicable Tumor evaluation (CT scan) performed within 4 weeks (28 days) prior to inclusion with at least one measurable lesion according to RECIST 1.1 criteria Patient fit and able to comply with the protocol for the duration of the study, including treatment, visits, scheduled examinations and follow-up. Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days) Information given and informed consent signed Patient affiliated to a social security scheme Men and women must have an effective contraceptive method. Exclusion Criteria: Patient with neuroendocrine carcinoma or acinar cell carcinoma Other cancer in the 5 years preceding inclusion or concomitant (except cancer in situ of the uterine cervix or cutaneous basal cell carcinoma). Presence of brain metastasis(es) Estimated prognosis < 3 months History of grade 4 toxicity to oxaliplatin, irinotecan or 5FU if history of adjuvant/neoadjuvant chemotherapy Sequellar toxicity > grade 1 if previous adjuvant/neoadjuvant chemotherapy Hypersensitivity to any component of FOLFIRINOX® treatment. Current participation or participation within 30 days prior to inclusion in another therapeutic trial with an investigational compound and/or completion of radiotherapy within 10 days prior to the start of treatment Evidence of a homozygous or heterozygous DPYD mutation and/or uracilemia >16ng/mL and/or homozygous UGT1A1 genotype. Pregnancy, breastfeeding Inability to sign informed consent or to undergo medical monitoring of the trial for geographical, social or psychological reasons including, but not limited to, psychiatric illness compromising comprehension of information or conduct of the study. Patient under guardianship, curatorship or safeguard of justice.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jean-David FUMET, Dr
    Phone
    380737538
    Ext
    +33
    Email
    jdfumet@cgfl.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sophie PARNALLAND, Project manager
    Phone
    345348077
    Ext
    +33
    Email
    sparnalland@cgfl.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy

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