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NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma (FOXAGAST)

26. februar 2019 opdateret af: GERCOR - Multidisciplinary Oncology Cooperative Group

Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma

This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.

In neoadjuvant setting : 3 months of treatment

Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.

Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the result of the neo-adjuvant treatment and the ability of patients to receive adjuvant chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks post-operatively.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.

In neoadjuvant setting : 3 months of treatment

Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

55

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Besancon, Frankrig, 25030
        • Rekruttering
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
        • Kontakt:
          • Telefonnummer: 33-3-8166-8393
        • Ledende efterforsker:
          • Stéphano KIM
      • Creteil, Frankrig, 94000
        • Rekruttering
        • Centre Hospitalier Universitaire Henri Mondor
        • Kontakt:
          • Telefonnummer: 33-1-4981-2579
      • Lyon, Frankrig
        • Rekruttering
        • Centre Leon Berard
      • Lyon, Frankrig
        • Rekruttering
        • Hôpital Privé Jean Mermoz
        • Ledende efterforsker:
          • Gérard LLEDO
      • Paris, Frankrig
        • Rekruttering
        • Hôpital Saint Antoine
        • Ledende efterforsker:
          • Thierry Andre
      • Paris, Frankrig
        • Rekruttering
        • Institut Mutualiste Montsouris
        • Kontakt:
          • Christophe, PhD
        • Ledende efterforsker:
          • Christophe LOUVET, PhD
      • Paris, Frankrig, 75651
        • Rekruttering
        • CHU Pitié-Salpêtrière
        • Ledende efterforsker:
          • Jean-Baptiste Bachet
        • Kontakt:
          • Telefonnummer: 33-1-42-16-00-00

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Signed and dated informed consent, and willing and able to comply with protocol requirements,
  • Histologically or cytologically proven adenocarcinoma of the low oesophagus or of the stomach, (from 1/3 inferior of the oesophagus to pylorus)
  • HER2 negative tumors
  • Localized and operable disease confirmed (stage I-III),
  • No prior therapy for localized disease ,
  • Age ≥18 years,
  • Performance status (PS) 0-2,
  • Haematological status: neutrophils (ANC) > 2.0x109/L; platelets >100x109/L; haemoglobin ≥9g/dL,
  • Adequate renal function: serum creatinine level <150µM and creatinine clearance test > 30mL/min,
  • Adequate liver function: AST (SGOT) and ALT (SGPT) ≤2.5xULN (Upper Limit of Normal)
  • Total bilirubin ≤1.5 x ULN,
  • Albumin ≥25g/L
  • Baseline evaluations performed before inclusion: clinical and blood evaluations no more than 2 weeks (14 days) prior to inclusion, tumor assessment (CT-scan, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to inclusion,
  • Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least six months after the end of study treatment (when applicable). All female patients with reproductive potential must have a negative pregnancy test (β HCG) within 72 hours days prior to starting nab-paclitaxel neo-adjuvant and adjuvant treatment. Breastfeeding is not allowed. Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment,
  • Registration in a national health care system (CMU included for France).

Exclusion Criteria:

  • Metastatic disease (stage IV)
  • Non operable primary tumor
  • Patient using warfarin,
  • Uncontrolled hypercalcemia (corrected serum calcium > 2.55 mmol/l),
  • Pre-existing permanent neuropathy (NCI grade ≥2),
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency,
  • Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
  • Treatment with any other investigational medicinal product within 28 days prior to study entry,
  • Other serious and uncontrolled non-malignant disease (eg. active infection requiring systemic therapy, coronary stenting or myocardial infarction or stroke in the past 6 months),
  • Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C.
  • Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
  • Patients with known allergy to any excipient of study drugs,
  • Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine and concomitant administration of prophylactic phenytoin
  • Patient with any medical or psychological condition, deemed by the investigator to likely interfere with patient's ability to sign informed consent or cooperate and participate in the study, including tutelage or guardianship.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: nab-paclitaxel + FOLFOX
nab-paclitaxel + FOLFOX nab-paclitaxel: 150 mg/m2 D1 every 2 weeks Leucovorin: 400 mg/m2 D1 every 2 weeks Oxaliplatin: 85 mg/m2 D1 every 2 weeks 5-FU infusion: 2400mg/m2 48h infusion every 2 weeks 6 pre-operative cycles 6 post-operative cycles (optional)
Medicin: nab-paclitaxel
nab-paclitaxel : 150 mg/m2 D1 every 2 weeks
Andre navne:
  • ABRAXANE
Medicin: FOLFOX
Leucovorin: 400 mg/m2 D1 every 2 weeks Oxaliplatin: 85 mg/m2 D1 every 2 weeks Fluorouracil (5-FU) infusion: 2400mg/m2 48h infusion every 2 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Complete pathological response rate
Tidsramme: after three months of neoadjuvant chemotherapy
after three months of neoadjuvant chemotherapy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Free Survival (DFS)
Tidsramme: time from the date of inclusion up to the date of disease progression or death whichever occurs last up to 7 years
time from the date of inclusion up to the date of disease progression or death whichever occurs last up to 7 years
Overall Survival (OS)
Tidsramme: time interval form the inclusion to the date of the death from any cause up to 7 years
time interval form the inclusion to the date of the death from any cause up to 7 years
Health related to Quality of Life (QoL)
Tidsramme: up to 8 months
up to 8 months
Safety profile of the combination of nab-paclitaxel + FOLFOX regimen assessed by adverse events
Tidsramme: time from randomisation up to end of study up to 7 years
time from randomisation up to end of study up to 7 years
Assessment of biomarkers when appropriate
Tidsramme: 1 day of biopsie from diagnosis, and tumor from surgery
such as SPARC, TS, DPD, ERCC1
1 day of biopsie from diagnosis, and tumor from surgery
Assessment of genetic polymorphism involved in tumor-response when appropriate
Tidsramme: 28 days after last study treatment
CYP2A6, TS, DPD, ERCC1, ERCC2
28 days after last study treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Samarbejdspartnere

Celgene Corporation

Efterforskere

  • Ledende efterforsker: Christophe LOUVET, Institut Mutualiste Montsouris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Faktiske)

1. oktober 2017

Studieafslutning (Forventet)

1. juni 2022

Datoer for studieregistrering

Først indsendt

12. juni 2015

Først indsendt, der opfyldte QC-kriterier

26. juni 2015

Først opslået (Skøn)

1. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FOXAGAST -D14-1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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