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NCT Number: NCT00278863

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-1

Drug

Capecitabine

Drug

Primary outcomes

  1. Response Rate

    Time frame: Up to 2 years

    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.

Secondary outcomes

  1. Number of Patients With Adverse Events

    Time frame: Up to 2 years

    Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 19, 2006
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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