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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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 Fluorouracil (5-FU) infusion: 2400mg/m2 48h infusion every 2 weeks
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France
RECRUITINGCentre Hospitalier Universitaire Henri Mondor
Créteil, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHôpital Privé Jean Mermoz
Lyon, France
RECRUITINGCHU Pitie-Salpetriere
Paris, France
RECRUITINGHopital Saint Antoine
Paris, France
RECRUITINGInstitut Mutualiste Montsouris
Paris, France
RECRUITINGComplete pathological response rate
Time frame: after three months of neoadjuvant chemotherapy
Disease Free Survival (DFS)
Time frame: 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)
Time frame: 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)
Time frame: up to 8 months
Safety profile of the combination of nab-paclitaxel + FOLFOX regimen assessed by adverse events
Time frame: time from randomisation up to end of study up to 7 years
Assessment of biomarkers when appropriate
such as SPARC, TS, DPD, ERCC1
Time frame: 1 day of biopsie from diagnosis, and tumor from surgery
Assessment of genetic polymorphism involved in tumor-response when appropriate
CYP2A6, TS, DPD, ERCC1, ERCC2
Time frame: 28 days after last study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.