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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Capecitabine	Capecitabine	-
S-1	S-1	-

Primary Outcome Measures

Name	Time	Method
Response Rate	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events	Up to 2 years	Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years

Locations (9): Seoul Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
National Cancer Center
🇰🇷
Goyang, Gyeonggi-do, Korea, Republic of
Kyung Pook National University Hospital
🇰🇷
Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷
Daegu, Korea, Republic of
Gacheon Medical School Gil Medical Center
🇰🇷
Incheon, Korea, Republic of
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷
Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷
Ulsan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷
Pyeongchon, Gyeonggido, Korea, Republic of