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NCT Number: NCT02352337

First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem

The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy.

Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin.

These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.

FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment.

The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU - Hôtel Dieu, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic disease
  • At least one mesurable lesion according to RECIST V1.1 criteria
  • No prior chemotherapy (excepted if there is at least on lestion out of the irradition area)
  • Age > 18 years. A favorable adviced by an onco geriatrician would be mandatory for inclusion of patients older than 75 older
  • Performance statut (WHO) 0-1
  • Polynyclear ≥ 1500/mm3
  • Bilirubine ≤ 1,5 fois la LSN, creatinin < 120μmol / L
  • Signed informed consent form

Exclusion criteria

  • Another type of pancreas tumor, as endocrine tumor ou with acinous cells
  • Ampulloma
  • Cerebral or meningeal metastasis
  • Gilbert disease
  • Neuropathie > or = grade 1
  • Study treatments contraindication
  • Uncontrolled diarrhoea or inflamatory disease of colon or rectum, or bowel obstruction or bowel sub-obstruction no resolved with specific treatment
  • Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease prevent patient to receive study Cancer within the 5 years before inclusion, except for int situ cancer of the neck of the uterus or basal cell skin cancer
  • Significant previous cardiac and respiratory disease
  • Patient included in an other therapeutic study with experimental treatment
  • Pregnancy or breast feeding
  • Patient depreved of freedom or under gardianship
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Treatment and study plan

Folfirinox

Drug

Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue

LV5FU2

Drug

Perfusion: Folinic Acid,5FU Bolus,5FU continue

FOLFIRI.3

Drug

Perfusion :Irinotecan,Acide folinique ,5FU continue

Gemcitabine

Drug

Gemcitabine perfusion

Primary outcomes

  1. Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization.

    Time frame: 6 months after randomization

    Progression was defined as radiological progression according to RECIST v1.1 criteria and/or clinical progression according to the investigator. Progression or death (for any reason) was considered if the event occured within the first 6 months since randomization. 6 month scans were 6 month scans with a +/- 1 month window.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 3 years after the treatment start

    Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account.

    The analysis was done on the ITT population meaning the patients who have been randomized. Numbers of patients correspond the number of patients randomized in the study.

  2. Progression-free Survival (PFS)

    Time frame: up to 12 months after randomization

    It was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news

    .

Sponsors and collaborators

Lead sponsor

Federation Francophone de Cancerologie Digestive

Other

Registry information

Official study title

Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line

Acronym: PANOPTIMOX

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Feb 2, 2015
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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