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A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.

Phase 2
18 Years
75 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.

Inclusion Criteria

Inclusion criteria:

- Patients with histologically confirmed, newly diagnosed, localized gastric or
gastro-esophageal adenocarcinoma, that is considered operable.

- The bulk of disease must be localized in the stomach, although the
gastroesophageal junction may be involved.

- Patients with T3 or T4 carcinoma without (N0) and T2 or T3 or T4 with regional
lymph node involvement assessed by EUS, no peritoneal seeding suspected on
abdomen-pelvic CT or confirmed by laparoscopy.

- Performance status 0-1 in ECOG scale

- Adequate haematological function and liver and kidney function within 7 days prior to

- Absolute neutrophil count > or = 1.5 x 10^9/L

- Platelets > or = 100 x 10^9/L

- Haemoglobin > 10 g/dl

- Calculated creatinine clearance > or = 60 ml/min

- Total bilirubin < or = 3 x UNL

- GOT and GPT < or = 3 x UNL

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:

- Unstable, persistent cardiac disease despite medicinal treatment, myocardial
infarction within 6 months before the start of the trial

- Chronic diarrhoea

- Neurological or psychological disorders including dementia and seizures

- Active, non-controllable infection or sepsis

- Actively disseminated intravascular coagulation

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

R0 resection rate

Outcome Time Frame:

At the end of the treatment period

Safety Issue:


Principal Investigator

Faith Fung

Investigator Role:

Study Director

Investigator Affiliation:



Korea: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

May 2012

Related Keywords:

  • Gastric Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms