Cancer of Stomach Clinical Trial
Official title:
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.
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.
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