Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00278863
First received: January 17, 2006
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: S-1
Drug: Capecitabine
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Toxicities, Time to treatment failure, PFS, OS, QOL

Enrollment: 96
Study Start Date: November 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S-1 Drug: S-1
Active Comparator: Capecitabine Drug: Capecitabine

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278863

Locations
Korea, Republic of
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggido, 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
Seoul Samsung Medical Center
Seoul, 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
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Yoon-Koo Kang, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00278863     History of Changes
Other Study ID Numbers: AMC0402
Study First Received: January 17, 2006
Last Updated: August 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
Stomach cancer
Palliative chemotherapy
Capecitabine
S-1

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Fluorouracil
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013