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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00278863
• Date of registration: 17/01/2006
• Primary sponsor: Asan Medical Center
• Public title: Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
• Scientific title: Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer
• Date of first enrolment: November 2004
• Target sample size: 96
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00278863
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Yoon-Koo Kang, M.D., Ph.D.
• Affiliation: Asan Medical Center

Key inclusion & exclusion 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.



Age minimum: 65 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Gastric Cancer

Intervention(s)

Drug: Capecitabine

Drug: S-1

Primary Outcome(s)

Response rate

Secondary Outcome(s)

Toxicities, Time to treatment failure, PFS, OS, QOL

Secondary ID(s)

AMC0402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors