Status:
COMPLETED
Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
Lead Sponsor:
Asan Medical Center
Conditions:
Gastric Cancer
Eligibility:
All Genders
65-85 years
Phase:
PHASE2
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 advanc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00278863
Start Date
November 1 2004
End Date
January 1 2007
Last Update
February 25 2014
Active Locations (9)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
2
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggido, South Korea
3
Kyung Pook National University Hospital
Daegu, South Korea
4
Yeungnam University Medical Center
Daegu, South Korea