- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Christophe LOUVET
- Número de telefone: 33 1 56 61 60 35
- E-mail: christophe.louvet@imm.fr
Locais de estudo
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-
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Besancon, França, 25030
- Recrutamento
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
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Contato:
- Número de telefone: 33-3-8166-8393
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Investigador principal:
- Stéphano KIM
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Creteil, França, 94000
- Recrutamento
- Centre Hospitalier Universitaire Henri Mondor
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Contato:
- Número de telefone: 33-1-4981-2579
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Lyon, França
- Recrutamento
- Centre Leon Berard
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Lyon, França
- Recrutamento
- Hopital Prive Jean Mermoz
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Investigador principal:
- Gérard LLEDO
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Paris, França
- Recrutamento
- Hopital Saint Antoine
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Investigador principal:
- Thierry Andre
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Paris, França
- Recrutamento
- Institut Mutualiste Montsouris
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Contato:
- Christophe, PhD
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Investigador principal:
- Christophe LOUVET, PhD
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Paris, França, 75651
- Recrutamento
- CHU Pitié-Salpêtrière
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Investigador principal:
- Jean-Baptiste Bachet
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Contato:
- Número de telefone: 33-1-42-16-00-00
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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
Outros nomes:
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Complete pathological response rate
Prazo: after three months of neoadjuvant chemotherapy
|
after three months of neoadjuvant chemotherapy
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Disease Free Survival (DFS)
Prazo: 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
|
|
Overall Survival (OS)
Prazo: 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
|
|
Health related to Quality of Life (QoL)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 28 days after last study treatment
|
CYP2A6, TS, DPD, ERCC1, ERCC2
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28 days after last study treatment
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Christophe LOUVET, Institut Mutualiste Montsouris
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Doenças do Estômago
- Neoplasias do Estômago
- Adenocarcinoma
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Paclitaxel
Outros números de identificação do estudo
- FOXAGAST -D14-1
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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