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

NCT ID: NCT00278863

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2007-01-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1

Group Type: ACTIVE_COMPARATOR

S-1

Intervention Type: DRUG

Capecitabine

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Interventions

S-1

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yoon-Koo Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoon-Koo Kang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Hallym University Sacred Heart Hospital

Pyeongchon, Gyeonggido, South Korea

Kyung Pook National University Hospital

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Gacheon Medical School Gil Medical Center

Incheon, , South Korea

Asan Medical Center

Seoul, , South Korea

Korea Cancer Center Hospital

Seoul, , South Korea

Seoul Samsung Medical Center

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

AMC-ONCGI-0415

Identifier Type: -

Identifier Source: org_study_id