Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma

Study Overview
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Brief Summary
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The primary objective of this trial is: To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved. The secondary objective of this trial are to describe: The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection. The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.

Official Title
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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.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: DOCETAXEL
* Drug: S-1
* Drug: OXALIPLATIN


Participation Criteria
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Eligibility Criteria
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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 enrollment: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy. | Drug: DOCETAXEL<br>* 50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.<br>Drug: S-1<br>* 80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.<br>Drug: OXALIPLATIN<br>* 100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate |  | At the end of the treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination |  | Every 3 months during the study period | 
| Chest X-Ray |  | Throughout the study period | 
| Computed Tomography scan of the abdomen |  | Every 6 months during the study period | 
| Gastrofiberscopy |  | Every 1 year from the completion of the treatment for 2 years | 
| Laboratory analysis |  | Throughout the study period |