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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Georges Francois Leclerc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • FOLFIRINOX treatment

    Drug

    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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: FOLFIRINOX treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

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

Time frame
6 months

Secondary outcomes

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.

Time frame
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.

Time frame
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

Time frame
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.

Time frame
Until the end of treatment an average of 14 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.