- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Christophe LOUVET
- Numero di telefono: 33 1 56 61 60 35
- Email: christophe.louvet@imm.fr
Luoghi di studio
-
-
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Besancon, Francia, 25030
- Reclutamento
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
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Contatto:
- Numero di telefono: 33-3-8166-8393
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Investigatore principale:
- Stéphano KIM
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Creteil, Francia, 94000
- Reclutamento
- Centre Hospitalier Universitaire Henri Mondor
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Contatto:
- Numero di telefono: 33-1-4981-2579
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Lyon, Francia
- Reclutamento
- Centre LEON BERARD
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Lyon, Francia
- Reclutamento
- Hopital Prive Jean Mermoz
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Investigatore principale:
- Gérard LLEDO
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Paris, Francia
- Reclutamento
- Hopital Saint Antoine
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Investigatore principale:
- Thierry Andre
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Paris, Francia
- Reclutamento
- Institut Mutualiste Montsouris
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Contatto:
- Christophe, PhD
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Investigatore principale:
- Christophe LOUVET, PhD
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Paris, Francia, 75651
- Reclutamento
- CHU Pitié-Salpêtrière
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Investigatore principale:
- Jean-Baptiste Bachet
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Contatto:
- Numero di telefono: 33-1-42-16-00-00
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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)
|
nab-paclitaxel : 150 mg/m2 D1 every 2 weeks
Altri nomi:
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Complete pathological response rate
Lasso di tempo: after three months of neoadjuvant chemotherapy
|
after three months of neoadjuvant chemotherapy
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Disease Free Survival (DFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: up to 8 months
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up to 8 months
|
|
Safety profile of the combination of nab-paclitaxel + FOLFOX regimen assessed by adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 28 days after last study treatment
|
CYP2A6, TS, DPD, ERCC1, ERCC2
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28 days after last study treatment
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Christophe LOUVET, Institut Mutualiste Montsouris
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Malattie dello stomaco
- Neoplasie allo stomaco
- Adenocarcinoma
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Paclitaxel
Altri numeri di identificazione dello studio
- FOXAGAST -D14-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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