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

Study Overview

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

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

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.

Metastatic Pancreatic Cancer

DRUG: FOLFIRINOX treatment

2023-505889-29-00

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-07-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-09
First Submitted that Met QC Criteria 2023-08-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-12
First Posted (ACTUAL) 2023-08-14	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFIRINOX treatment 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 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFIRINOX treatment

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

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 Measures	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival (PFS) on FOLFIRINOX3 at 6 months.	6 months

Secondary Outcome Measures	Measure Description	Time Frame
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.	24 months
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.	Until 30 days after the end of treatment
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	Until the end of treatment an average of 14 months
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.	Until the end of treatment an average of 14 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jean-David FUMET, Dr

Phone Number: 380737538

Email: jdfumet@cgfl.fr

Study Contact Backup

Name: Sophie PARNALLAND, Project manager

Phone Number: 345348077

Email: sparnalland@cgfl.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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