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

Gastric Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278863
• Other study ID #: AMC-ONCGI-0415
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2006
• Last updated: January 13, 2014
• Start date: November 2004
• Est. completion date: January 2007

Study information

• Verified date: January 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1

• Capecitabine

Locations

Country	Name	City	State
Korea, Republic of	Kyung Pook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do
Korea, Republic of	Gacheon Medical School Gil Medical Center	Incheon
Korea, Republic of	Hallym University Sacred Heart Hospital	Pyeongchon	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Seoul Samsung Medical Center	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Patients With Adverse Events	Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years	Up to 2 years	No