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- Klinische proef NCT02486601
NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma (FOXAGAST)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Christophe LOUVET
- Telefoonnummer: 33 1 56 61 60 35
- E-mail: christophe.louvet@imm.fr
Studie Locaties
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Besancon, Frankrijk, 25030
- Werving
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
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Contact:
- Telefoonnummer: 33-3-8166-8393
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Hoofdonderzoeker:
- Stéphano KIM
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Creteil, Frankrijk, 94000
- Werving
- Centre Hospitalier Universitaire Henri Mondor
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Contact:
- Telefoonnummer: 33-1-4981-2579
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Lyon, Frankrijk
- Werving
- Centre Léon Bérard
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Lyon, Frankrijk
- Werving
- Hopital Prive Jean Mermoz
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Hoofdonderzoeker:
- Gérard LLEDO
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Paris, Frankrijk
- Werving
- Hôpital Saint Antoine
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Hoofdonderzoeker:
- Thierry Andre
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Paris, Frankrijk
- Werving
- Institut Mutualiste Montsouris
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Contact:
- Christophe, PhD
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Hoofdonderzoeker:
- Christophe LOUVET, PhD
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Paris, Frankrijk, 75651
- Werving
- CHU Pitié-Salpêtrière
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Hoofdonderzoeker:
- Jean-Baptiste Bachet
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Contact:
- Telefoonnummer: 33-1-42-16-00-00
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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)
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nab-paclitaxel : 150 mg/m2 D1 every 2 weeks
Andere namen:
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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Complete pathological response rate
Tijdsspanne: after three months of neoadjuvant chemotherapy
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after three months of neoadjuvant chemotherapy
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Disease Free Survival (DFS)
Tijdsspanne: time from the date of inclusion up to the date of disease progression or death whichever occurs last up to 7 years
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time from the date of inclusion up to the date of disease progression or death whichever occurs last up to 7 years
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Overall Survival (OS)
Tijdsspanne: time interval form the inclusion to the date of the death from any cause up to 7 years
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time interval form the inclusion to the date of the death from any cause up to 7 years
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Health related to Quality of Life (QoL)
Tijdsspanne: up to 8 months
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up to 8 months
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Safety profile of the combination of nab-paclitaxel + FOLFOX regimen assessed by adverse events
Tijdsspanne: time from randomisation up to end of study up to 7 years
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time from randomisation up to end of study up to 7 years
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Assessment of biomarkers when appropriate
Tijdsspanne: 1 day of biopsie from diagnosis, and tumor from surgery
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such as SPARC, TS, DPD, ERCC1
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1 day of biopsie from diagnosis, and tumor from surgery
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Assessment of genetic polymorphism involved in tumor-response when appropriate
Tijdsspanne: 28 days after last study treatment
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CYP2A6, TS, DPD, ERCC1, ERCC2
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28 days after last study treatment
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Christophe LOUVET, Institut Mutualiste Montsouris
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Maagneoplasmata
- Adenocarcinoom
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Paclitaxel
Andere studie-ID-nummers
- FOXAGAST -D14-1
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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HutchmedNog niet aan het werven
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Fundacion OncosurVoltooid
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Changhai HospitalWerving
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CelgeneVoltooidColorectale neoplasmataFrankrijk
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