A Phase III, Open-labelled, Randomised Study of Neoadjuvant Docetaxel+Oxaliplatin+S-1 (DOS) + Surgery + Adjuvant S-1 Versus Surgery + Adjuvant S-1 in Patients With Resectable Advanced Gastric Cancer
Inclusion Criteria
Inclusion criteria :
- Patients with histologically confirmed, newly diagnosed, localized gastric or
gastro-oesophageal adenocarcinoma, that is considered resectable
- Patients with clinical stage(T2-3/N(+), T4/N(+/-) :N positive means ≥8 in short axis)
- Signed informed consent
Exclusion criteria:
- Age <20 years or ≥76 years Performance status ≥2 in Eastern Cooperative Oncology
Group (ECOG) scale
- The patients who have the history of other malignancy within the last five years
except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
which have been already successfully treated
- Previous surgery on neoplasm of stomach
- Patients who have not completely recovered from surgery
- Distant metastases (M1) to other organs including distant nodal groups
(retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node).
severe/unstable angina, coronary artery bypass graft, congestive heart failure,
transient ischemic attack within 6 months prior to enrollment in the study
- Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy
and/or immunotherapy, for the currently treated gastric cancer
- Patients with active active infection or sepsis
- Intolerance of oral taking or malabsorption: lack of physical integrity of the upper
gastrointestinal tract or those who have malabsorption syndrome likely to influence
absorption of TS-1. 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 and indications of resorption disorders after intestinal surgery
- ≥ grade 2 severe tumour haemorrhage
- Simultaneous participation in another study, or participation in another study within
4 weeks of commencement of this study
- Pregnant or lactating patients
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.