NCT05988814

Brief Summary

Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
38mo left

Started Jan 2024

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jan 2024Jul 2029

First Submitted

Initial submission to the registry

July 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 24, 2024

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2029

Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

5.5 years

First QC Date

July 20, 2023

Last Update Submit

February 9, 2024

Conditions

Metastatic Pancreatic Cancer

Keywords

FOLFIRINOX treatmentpancreatic cancerfirst line chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

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

    6 months

Secondary Outcomes (4)

  • Overall survival (OS)

    24 months

  • Acute and late toxicities (adverses events)

    Until 30 days after the end of treatment

  • Quality of life (QoL)

    Until the end of treatment an average of 14 months

  • Quality of life (QoL)

    Until the end of treatment an average of 14 months

Study Arms (1)

FOLFIRINOX treatment

EXPERIMENTAL

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.

Drug: FOLFIRINOX treatment

Interventions

FOLFIRINOX treatmentDRUG

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

FOLFIRINOX treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patient fit and able to comply with the protocol for the duration of the study, including treatment, visits, scheduled examinations and follow-up.
  • Information given and informed consent signed
  • Patient affiliated to a social security scheme
  • Men and women must have an effective contraceptive method.

You may not qualify if:

  • Patient with neuroendocrine carcinoma or acinar 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Georges-François Leclerc

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Jean-David FUMET, Dr

CONTACT

380737538jdfumet@cgfl.fr

Sophie PARNALLAND, Project manager

CONTACT

345348077sparnalland@cgfl.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 14, 2023

Study Start

January 24, 2024

Primary Completion (Estimated)

July 24, 2029

Study Completion (Estimated)

July 24, 2029

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

FR(1)