Status and phase
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The primary objective of this trial is:
The secondary objective of this trial are to describe:
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Inclusion and exclusion criteria
Inclusion criteria:
Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-esophageal adenocarcinoma, that is considered operable.
Performance status 0-1 in ECOG scale
Adequate haematological function and liver and kidney function within 7 days prior to enrollment:
Exclusion Criteria
Previous surgery on primary tumour
Prior palliative surgery (open and closure, passage operation)
Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated
Distant metastases (M1) including distant nodal Groups (Retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node)
Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy
Simultaneous therapy with other anti-tumour drugs
Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine, indications of resorption disorders after intestinal surgery
Evidence of gastric outlet obstruction and /or severe tumor hemorrhage
Other anamnestic reaction, serious illness or other medical conditions:
Symptomatic peripheral neuropathy NCI CTC version 3.0 grade > or = 1
Hypersensitivity to study drugs
Patients under anticoagulant therapy with warfarin or other coumarines are excluded from participation.
Pregnant or lactating (in case of potentially childbearing woman, pregnancy test is positive)
Patients of child-bearing age or the potential to father a child who refuse to use adequate contraception
Drug, substance or alcohol abuse
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
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Interventional model
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41 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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