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Metastatic Pancreatic CancerPhase 2PANOPTIMOXNCT02352337

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

A Phase 2 study testing FOLFIRINOX, LV5FU2 and FOLFIRI.3 in people with Metastatic Pancreatic Cancer, run by Federation Francophone de Cancerologie Digestive at 54 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. 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, LV5FU2 and FOLFIRI.3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
54 sitesFrance
Study dates
12 Jan 2015to Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

France54 sites

  • CHU - Hôtel Dieu

    Angers

  • CH

    Auxerre

  • CH - Henri Duffaut

    Avignon

  • Centre d'oncologie et de radiothérapie

    Bayonne

  • CH

    Bayonne

  • Ch - Ch Beauvais

    Beauvais

  • CHU

    Besançon

  • Bezier Ch

    Béziers, 34525

  • Hôpital Avicenne

    Bobigny

  • Polyclinique Bordeaux Nord

    Bordeaux

  • CH -Duchenne

    Boulogne-sur-Mer

  • CHU Côte de Nacre

    Caen

  • CHU Estaing

    Clermont-Ferrand

  • Hôpitaux Civils de Colmar

    Colmar

  • CH Compiègne-Noyon

    Compiègne

  • CHG

    Corbeil-Essonnes

  • CHU - Hôpital François Mitterand

    Dijon

  • CH

    Dunkirk

  • CHU de Grenoble

    Grenoble

  • Institut Daniel Hollard / Groupe Hospitalier Mutualiste

    Grenoble

  • Clinique Sainte Marguerite

    Hyères

  • CH Marne La Vallée Jossigny

    Jossigny

  • CHD

    La Roche-sur-Yon

  • CHU - Claude Huriez

    Lille

  • Hôpital du Scorff

    Lorient

  • CHU - Hôpital Edouard Herriot

    Lyon

  • Clinique de la Sauvegarde

    Lyon

  • Hôpital de la Croix Rousse

    Lyon

  • Hôpital Privé Jean Mermoz

    Lyon

  • La Timone

    Marseille, 13000

  • Hôpital Européen de Marseille

    Marseille

  • Hôpital privé

    Marseille

  • CH - Centre Hospitalier de Meaux

    Meaux

  • Centre Antoine Lassagne

    Nice

  • Hôpital de la Source -service HGE et cancérologie digestive

    Orléans

  • Hôpital de la Source- service d'oncologie

    Orléans

  • CHU AP - HP - Hôpital Européen Georges Pompidou

    Paris

  • Groupe Hospitalier Saint Joseph

    Paris

  • Hôpital La Pitié Salpetière

    Paris

  • CH Pau

    Pau

  • Centre Hospitalier Annecy Genevois

    Pringy

  • CHU Robert Debré

    Reims

  • Centre Eugène Marquis

    Rennes

  • CHU - Charles Nicolle

    Rouen

  • CHU

    Saint-Etienne

  • CH

    Soissons

  • CH

    St-Malo

  • Centre Paul Strauss

    Strasbourg

  • Clinique Sainte Anne

    Strasbourg

  • CH - Bigorra

    Tarbes

  • Hôpityal Trousseau

    Tours

  • CH

    Valenciennes

  • Institut Gustave Roussy

    Villejuif

  • Hôpital Privé de Villeneuve d'Ascq

    Villeneuve-d'Ascq

Other trials in France

About this study

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

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.

Read more

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.

Being tested
FOLFIRINOX, LV5FU2, FOLFIRI.3, Gemcitabine
Keywords
cancer, pancreatic cancer, metastatic pancreatic cancer
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

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

  • FOLFIRINOXDrug

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

  • LV5FU2Drug

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

  • FOLFIRI.3Drug

    Perfusion :Irinotecan,Acide folinique ,5FU continue

  • GemcitabineDrug

    Gemcitabine perfusion

Study groups in NCT02352337
Study groupRoleWhat they receive
FOLFIRINOXActive comparatorEvery two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours
Receives: Drug: FOLFIRINOX
FOLFIRINOX + LV5FU2 in maintenanceExperimentalFolfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours.
Receives: Drug: FOLFIRINOX; Drug: LV5FU2
FIRGEMExperimentalAlternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest )
Receives: Drug: FOLFIRI.3; Drug: Gemcitabine

What is being measured

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

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

    Measured: 6 months after randomization

Secondary outcomes (2)

  1. Overall Survival (OS)

    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.

    Measured: Up to 3 years after the treatment start

  2. Progression-free Survival (PFS)

    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

    .

    Measured: up to 12 months after randomization

Timeline

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

  1. First posted2 Feb 2015 (estimated)
  2. Study start12 Jan 2015
  3. Primary completionDec 2017
  4. Study completionAug 2021

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02352337
Sponsor's protocol ID
PRODIGE35
Acronym
PANOPTIMOX
Status last verified
Jul 2024
First submitted
14 Jan 2015
Last updated
10 Jul 2024
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Dahan L, Williet N, Le Malicot K, Phelip JM, Desrame J, Bouche O, Petorin C, Malka D, Rebischung C, Aparicio T, Lecaille C, Rinaldi Y, Turpin A, Bignon AL, Bachet JB, Seitz JF, Lepage C, Francois E; PRODIGE 35 Investigators/Collaborators. Randomized Phase II Trial Evaluating Two Sequential Treatments in First Line of Metastatic Pancreatic Cancer: Results of the PANOPTIMOX-PRODIGE 35 Trial. J Clin Oncol. 2021 Oct 10;39(29):3242-3250. doi: 10.1200/JCO.20.03329. Epub 2021 Jul 21.

    PubMed 34288696

  • Boisteau E, Dahan L, Williet N, Le Malicot K, Desrame J, Bouche O, Petorin C, Malka D, Rebischung C, Aparicio T, Lecaille C, Rinaldi Y, Turpin A, Bignon AL, Bachet JB, Lepage C, Granger V, Legoux JL, Deplanque G, Baconnier M, Lecomte T, Bonnet I, Seitz JF, Francois E, Lievre A; PRODIGE 35 Investigator/Collaborators. Clinico-biological factors predicting the benefit of the LV5FU2 maintenance strategy as a first-line therapy in patients with metastatic pancreatic cancer. Oncologist. 2024 Sep 6;29(9):e1149-e1158. doi: 10.1093/oncolo/oyae079.

    PubMed 39235326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRINOX, LV5FU2 and FOLFIRI.3 in people with Metastatic Pancreatic Cancer, run by Federation Francophone de Cancerologie Digestive at 54 sites 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites 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?

Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization. (time frame: 6 months after randomization). 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 NCT02352337, which also lists 2 linked publications.

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 10 Jul 2024.

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