Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial

Study Overview
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Brief Summary
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A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.

Official Title
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Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: S-1
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven gastric or gastroesophageal junction adenocarcinoma Metastatic or recurrent unresectable disease Measurable lesions (according to Response Evaluation Criteria in Solid Tumors [RECIST]) Age: 65-85 years old Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl) Adequate renal function (serum creatinine≤ 1.5) Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL) No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient Exclusion Criteria: Previous palliative chemotherapy Known allergy to study drugs CNS metastasis Significant medical comorbidities Active ongoing infection which antibiotic treatment is needed. Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S-1<br> | Drug: S-1<br> <br> |
| Active Comparator: Capecitabine<br> | Drug: Capecitabine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events | Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-1, Stomach cancer, Palliative chemotherapy, Capecitabine