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Brief Title: NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma
Official Title: Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma
Study ID: NCT02486601
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
Centre Léon Bérard, Lyon, , France
Hôpital Privé Jean Mermoz, Lyon, , France
CHU Pitie-Salpetriere, Paris, , France
Hopital Saint Antoine, Paris, , France
Institut Mutualiste Montsouris, Paris, , France
Name: Christophe LOUVET
Affiliation: Institut Mutualiste Montsouris
Role: PRINCIPAL_INVESTIGATOR