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Metastatic Pancreatic CancerPhase 2FOLFIRINOX3 PNCT05988814

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

A Phase 2 study testing FOLFIRINOX treatment in people with Metastatic Pancreatic Cancer, run by Centre Georges Francois Leclerc at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
FOLFIRINOX treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
24 Jan 2024to 24 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-David FUMET, Dr contact

380737538 ext. +33

jdfumet@cgfl.fr

Sophie PARNALLAND, Project manager contact

345348077 ext. +33

sparnalland@cgfl.fr

France1 site, 1 recruiting

  • Centre Georges-François Leclerc

    Dijon, 21000

    Fumet Jean David, Dr, 03 80 73 75 00 ext. +33, jdfumet@cgfl.fr

    Sophie Parnalland, 03 45 34 80 77 ext. +33, sparnalland@cgfl.fr

    Recruiting

Other trials in France

About this study

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)

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

Read the 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.

Being tested
FOLFIRINOX treatment
Keywords
FOLFIRINOX treatment, pancreatic cancer, first line chemotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05988814
Study groupRoleWhat they receive
FOLFIRINOX treatmentExperimentalTreatment 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.
Receives: Drug: FOLFIRINOX treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

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

    Measured: 6 months

Secondary outcomes (4)

  1. 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.

    Measured: 24 months

  2. 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.

    Measured: Until 30 days after the end of treatment

  3. 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

    Measured: Until the end of treatment an average of 14 months

  4. 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.

    Measured: Until the end of treatment an average of 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start24 Jan 2024
  3. Primary completion24 Jul 2029 (estimated)
  4. Study completion24 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05988814
Sponsor's protocol ID
2023-505889-29-00
Other IDs
2023
Acronym
FOLFIRINOX3 P
Status last verified
Feb 2024
First submitted
20 Jul 2023
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRINOX treatment in people with Metastatic Pancreatic Cancer, run by Centre Georges Francois Leclerc at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-David FUMET, Dr (380737538 ext. +33, jdfumet@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05988814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.

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