XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

Study Overview
=================
Brief Summary
-----------------
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.

Detailed Description
-----------------
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.

Official Title
-----------------
A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach

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

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages Eligible for Study: 65 Years or older Genders Eligible for Study: Both The Eastern Cooperative Oncology Group (ECOG) status ≤ 2 Histologically confirmed gastric adenocarcinoma(including LAUREN type). Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1). chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months. Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN. No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer. Able to accept oral medication Compliance with protocol Exclusion Criteria: Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids. Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix. Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders. clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months. Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine. Organ transplantation requires immunosuppressive treatment. Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases. Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN. Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD). Allergy to Oxaliplatin or any study medication ingredients.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XELOX-X<br>XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance. X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance. | Drug: Oxaliplatin<br>* Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks<br>* Other names: L-OHP;Drug: Capecitabine<br>* capecitabine 850mg/m2 bid, d1-14, every 3 weeks<br>* Other names: XELODA;|
| Active Comparator: XELOX<br>XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance. | Drug: Oxaliplatin<br>* Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks<br>* Other names: L-OHP;Drug: Capecitabine<br>* capecitabine 850mg/m2 bid, d1-14, every 3 weeks<br>* Other names: XELODA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | from the date of randomization until death from any cause or up to 1 year | 
| Response Rate (RR) |  | evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks | 
| adverse events (AE) |  | from date of randomization to 28 days after the last chemo dosage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly Gastric Cancer, Capecitabine Maintenance