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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-paclitaxel + FOLFOX | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | nab-paclitaxel : 150 mg/m2 D1 every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete pathological response rate | after three months of neoadjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DFS) | 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 interval form the inclusion to the date of the death from any cause up to 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe LOUVET | Contact | 33 1 56 61 60 35 | christophe.louvet@imm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe LOUVET | Institut Mutualiste Montsouris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Recruiting | Besançon | 25030 | France |
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| FOLFOX | Drug | 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 |
|
| Health related to Quality of Life (QoL) | up to 8 months |
| Safety profile of the combination of nab-paclitaxel + FOLFOX regimen assessed by adverse events | time from randomisation up to end of study up to 7 years |
| Assessment of biomarkers when appropriate | such as SPARC, TS, DPD, ERCC1 | 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 | 28 days after last study treatment |
| Centre Hospitalier Universitaire Henri Mondor | Recruiting | Créteil | 94000 | France |
|
| Centre Léon Bérard | Recruiting | Lyon | France |
|
| Hôpital Privé Jean Mermoz | Recruiting | Lyon | France |
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| CHU Pitie-Salpetriere | Recruiting | Paris | 75651 | France |
|
| Hopital Saint Antoine | Recruiting | Paris | France |
|
| Institut Mutualiste Montsouris | Recruiting | Paris | France |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| C410216 | Folfox protocol |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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