Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Early stage diagnosis of gastric cancer has ensued different approaches in its resection strategies. In order to increase the proportion of cases that undergo radical resection and reduce the recurrence rate, different pre-operative treatments are introduced. Here, the investigators investigate an active preoperative chemotherapeutic regimen to in patients with locally advanced gastric cancer.

Official Title
-----------------
Phase 2 Study of Response Rate and Side Effects of Preoperative Chemotherapy With Docetaxel, Oxaliplatin and Capcitabine (TOX) in Patients With Locally Advanced Operable Gastric Adenocarcinoma

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: TOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tissue diagnosis of gastric or gastroesophageaql junction Adenocarcinoma T3, T4 any N with non metastatic condition Age 18 - 70 years Performance status 0,1 according to ECOG criteria Adequate bone marrow , liver and renal function Hemoglobin ≥ 11 g/dl Platelets ≥ 100000 / mm3 Absolute Neutrophil Count ≥ 1500/mm3 Normal Bilirubin Normal Transaminases Normal creatinin Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM, cardiopulmonary disease) Exclusion Criteria: Any metastatic disease, T1, T2, N0

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pathological Response<br> | Drug: TOX<br>* oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Response rate | A single expert pathologist evaluates the pathologic outcome of the chemotherapy regimen after the completion of courses. Participants are divided into 3 groups including complete pathologic response, partial pathologic response and pathologic stable disease. | Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical Response rate | A single expert clinician evaluates the clinical outcome of the chemotherapy regimen after 2 primary courses 3 weeks apart. Evaluation is done with regards to the TNM scoring of gastric cancer (T for the size and expansion of the tumor, N for lymph node involvement, M for distant metastasis). Participants are divided into 4 groups including clinically progressive disease, complete clinical response, partial clinical response and clinically stable disease. | Participants are assessed after 2 courses of Chemotherapy 3 weeks apart, an expected period of 6 weeks from starting the study treatment protocol. |